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 used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
This recall has been terminated (originally issued December 2, 2008).
- Company
- Medtronic, Inc.
- Recall Initiated
- October 7, 2008
- Posted
- December 2, 2008
- Terminated
- June 7, 2011
- Recall Number
- Z-0441-2009
- Quantity
- 1,830
- Firm Location
- Danvers, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to insert the guidewire through the 18 gauge introducer needle
Distribution
Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
Lot / Code Info
Lot Number: 20111256
Root Cause
Nonconforming Material/Component
Action Taken
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.