—#74672

Product

6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K955785
Affected lot / code info: Lot Number: 20105869 and 20111254

Why it was recalled

Failure to insert the guidewire through the 18 gauge introducer needle

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic, Inc.
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern: Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.

Timeline

Recall initiated: 2008-10-07
Posted by FDA: 2008-12-02
Terminated: 2011-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.