Devices

Device Recall Zilver

  • Model / Serial
    Lot 1557057.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    California, Pennsylvania, Utah and Canada.
  • Product Description
    Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40.
  • Manufacturer
    Cook, Inc.
  • 1 Event

Manufacturer

Cook, Inc.
  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

Device Recall Zilver 518RX Vascular Stent
  • Model / Serial
    Catalog Prefix ZIVX5. All Lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Worldwide
  • Product Description
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
  • Manufacturer
    Cook Medical Incorporated
Device Recall Zilver
  • Model / Serial
    Reorder #ZILBS-6-6 ZILBS-10-8, ZILBS10-6, Amended 8/8/2003 to include: ZILBS-10-4, ZILBS-8-4, ZILBS-8-6, ZILBS-8-8, ZILBS6-4, ZILBS-6-8
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed to hospitals located nationwide and worldwide.
  • Product Description
    Zilver Expandable Metal Biliary Stent
  • Manufacturer
    Wilson-Cook Medical Inc
Device Recall Zilver Expandable Metal Biliary Stent System.
  • Model / Serial
    Catalog number: ZILBS-10-4, ZILBS-6-4, ZILBS-8-4, ZILBS-10-6, ZILBS-6-6, ZILBS-8-6, ZILBS-10-8, ZILBS-6-8, ZILBS-8-8, Lot number: 1616783, 1616787, 1622794, 1622798, 1622802, 166958, 1622966, 162970, 162993, 1623007, 1623016, 1626424, 1631805, 1616784, 1616788, 1622795, 1622799, 1622803, 1622959, 1622803, 1622959, 1622963, 1622967, 1622982, 1622994, 1623008, 1623017, 1631388, 1633707, 1616785, 1616789, 1622796, 1622800, 1622804, 1622960, 1622964, 1622968, 1622985, 1623001, 1623009, 1623018, 1631803, 1634239, 1616786, 1616790, 1622797, 1622801, 1622956, 1622961, 1622965, 1622969, 1622986, 1623002, 1623015, 1626423, 1631804, 1635626.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The device was distributed nationwide, Ireland and Jordan.
  • Product Description
    ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
  • Manufacturer
    Wilson-Cook Medical Inc
Device Recall Zilver 518 Vascular Self Expanding Stent
  • Model / Serial
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • Product Description
    Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
  • Manufacturer
    Cook Ireland Ltd.