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7 F BardSelect 11cm Percutaneous Catheter Introducer Set recallZ-0443-2009 · Medtronic, Inc. · initiated Oct 7, 2008

Terminated All recalls posted in December 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Failure to insert the guidewire through the 18 gauge introducer needle

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0443-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 7, 2008
Posted by the FDA
Dec 2, 2008
Recalling firm
Medtronic, Inc.
Quantity
1,805 units
Product code
DYB
FDA submissions
K955785
Distribution
Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.

Product description

7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 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.

Code information (models, lots, serial numbers)

Lot Number: 21111255

Other devices under the same FDA submission

4 devices cleared under K955785 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 50078).

Sources and updates

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