Recall Z-2623-2016 ยท DQY Catheter, Percutaneous
Cook Inc.
White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
| Date | Aug 22, 2016 (initiated Apr 15, 2016) |
| Status | Terminated |
| Reason | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs. |
| Root cause | Unknown/Undetermined by firm |
| Action | Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067. |
| Quantity | 3,425 |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902905 | COOK CORONARY GUIDING CATHETER Cook, Inc., Sep 4, 1990 |