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  • Device 2359
  • Manufacturer 570
  • Event 124969
  • Implant 153
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: FR6J0264, and  FR6K0311
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090403CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: R58287298, 58290067, R58327648, 58415744,  B58452193, FR6J0247, and  FR6K0299
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090601CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: R58346066, and FR6J0253
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090603CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: R58340557, FR6J0248,  FR6K0300, and FR6K0344
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090801CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: BR58429040, BR58429176, R58432237, FR6J0254, and  FR6K0313
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090803CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: 58285863, FR6H0185, and  FR6J0249
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Number FR6K0276
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: FR6H0172,  FR6J0250,  FR6K0322,  FR6K0340, and  R58287299
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: 58290197, and FR6K0330
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: FR6K0277A,  FR6K0307,  FR6K0323,  R58279724, R58285864, R58308046, and R58316537
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: FR6H0153,  FR6K0289, and FR6K0331
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100403CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: R58285865, R58312972, 58337682, 58415748, FR6J0229, and RFR6K0303
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100601CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: 58266139, 58332065, 58424739, FR6J0241, and  FR6K0332
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100603CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: R58300437, R58330672, and FR6K0286
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100801CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: R58266280, 58406020, FR6K0280,  FR6K0333, and  FR6J0242
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100803CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Number FR6K0281
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100903CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall LifeStent FlexStar Stent System
  • Model / Serial
    Lot Numbers: FR6K0279, and FR6K0335
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall LifeStent FlexStar Stent System
Device Recall Bard/Davol
  • Model / Serial
    Lot Code: 43JQD016
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Bard 3D Max Mesh, Left large , Sterile || Pre-formed Knitted Polypropylene || Product Code: 0151531 || Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.
  • 1 Event
    • Recall of Device Recall Bard/Davol
Device Recall BARD E LUMINEXX BILIARY STENT
  • Model / Serial
    Lot Number: ANSJ0893.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Product Description
    Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall BARD E LUMINEXX BILIARY STENT
Device Recall BARD E LUMINEXX BILIARY STENT
  • Model / Serial
    Lot Number: ANSG2329.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Product Description
    Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall BARD E LUMINEXX BILIARY STENT
Device Recall BARD E LUMINEXX BILIARY STENT
  • Model / Serial
    Lot Number: ANSG2333.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Product Description
    Bard E LUMINEXX, Biliary Stent Size: 6mm x 80mm, Product Number: ZBL06080.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall BARD E LUMINEXX BILIARY STENT
Device Recall BARD E LUMINEXX BILIARY STENT
  • Model / Serial
    Lot Number: ANSH0164.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Product Description
    Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBL12040.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall BARD E LUMINEXX BILIARY STENT
Device Recall BARD E LUMINEXX BILIARY STENT
  • Model / Serial
    Lot Number: ANSH0165.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Product Description
    Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall BARD E LUMINEXX BILIARY STENT
Device Recall BARD E LUMINEXX BILIARY STENT
  • Model / Serial
    Lot Number: ANSH0293.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Product Description
    Bard E LUMINEXX Biliary Stent,Size: 6mm x 20mm, Product Number: ZBM06020.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall BARD E LUMINEXX BILIARY STENT
Device Recall BARD E LUMINEXX BILIARY STENT
  • Model / Serial
    Lot Number: ANSG2286.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AR, CA, CT, DE, FL, GA, IL, IN, KY, MA, MD, MO, MS, NC, ND, NJ, NM, NY, OH, PA, TN, TX, VA and WI.
  • Product Description
    Bard E LUMINEXX Biliary Stent, Size: 6mm x 30mm, Product Number: ZBM06030.
  • Manufacturer
    Bard Peripheral Vascular Inc
  • 1 Event
    • Recall of Device Recall BARD E LUMINEXX BILIARY STENT
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About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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