Recall Z-0441-2009 ยท DYB Introducer, Catheter
Medtronic, Inc.
5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are u
| Date | Dec 2, 2008 (initiated Oct 7, 2008) |
| Status | Terminated |
| Reason | Failure to insert the guidewire through the 18 gauge introducer needle |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation. |
| Quantity | 1,830 |
| Distribution | Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955785 | TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET C.R. Bard, Inc., Mar 12, 1996 |