Events

Recall of Embolectomy Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Medical Resources Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63100
  • Event Risk Class
    Class 2
  • Event Number
    Z-2446-2012
  • Event Initiated Date
    2012-08-09
  • Event Date Posted
    2012-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112546
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, embolectomy - Product Code DXE
  • Reason
    Applied medical is recalling specific lot numbers of its vascular catheters because they may have a potential for packaging particulate matter to reside on the product.
  • Action
    Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to complete the attached Recall Notification Confirmation Form and to return it to the firm via e-mail to recall60476587@appliedmedical.com or fax to (949) 713-8832. For product return questions, customers were instructed to contact Sales Operations Administrator at (949) 713-8652.For questions regarding this recall contact the firm at (949) 713-8041.

Device

Embolectomy Catheters
  • Model / Serial
    Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.
  • Product Description
    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): || Model Numbers & Description: || A4402, 3F-40CM, SYNTEL RT-EMB; || A4403, 3F-80CM, SYNTEL RT-EMB; || A4404, 4F-40CM, SYNTEL RT-EMB; || A4405, 4F-80CM, SYNTEL RT-EMB; || A4406, 5F-80CM, SYNTEL RT-EMB; || A4407, 6F-80CM, SYNTEL RT-EMB; || A4408, 7F-80CM, SYNTEL RT-EMB; || A4F00, 2F-60CM (PREM) SYNTEL CATHETER; || A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; || A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; || A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; || A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; || A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; || A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; || A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; || A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; || CE0260ST, L2F-60CM PREM SYNTEL CATH; || CE0280ST, L2F-80CM PREM SYNTEL CATH; || CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; || CE0380ST, 3F-80CM PREM SYNTEL CATH; || CE0440ST, 4F-40CM PREM SYNTEL CATH; || CE0480ST, 4F-80CM PREM SYNTEL CATH; || CE0580ST, 5F-80CM PREM SYNTEL CATH; || CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; || CE0780ST, 7F-80CM PREM SYNTEL CATH; || CE0340, 3F-40cm, SYNTEL RT-EMB; || CE0380, 3F-80cm, SYNTEL RT-EMB; || CE0440, 4F-40cm, SYNTEL RT-EMB; || CE0480, 4F-80cm, SYNTEL RT-EMB; || CE0580, 5F-80cm, SYNTEL RT-EMB; || CE0680, 6F-80cm, SYNTEL RT-EMB; || CE0780, 7F-80cm SYNTEL RT-EMB. || BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Manufacturer Address
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Manufacturer Parent Company (2017)
    Applied Medical Corporation
  • Source
    USFDA