Z-0442-2009

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

Name: Z-0442-2009 6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets...
Creator: Medtronic, Inc.
Published: 2008-10-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-10-07 / Terminated / root cause: manufacturing process

FDA source

Medtronic, Inc. began a recall of 6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle... on 2008-10-07. The reason FDA records is "Failure to insert the guidewire through the 18 gauge introducer needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0442-2009
Status: Terminated
Initiated: 2008-10-07
Posted: 2008-12-02
Terminated: 2011-06-07
Recalling firm: Medtronic, Inc.
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.
Product code: DYB Introducer, Catheter
Reason for recall: Failure to insert the guidewire through the 18 gauge introducer needle
Root cause tag: manufacturing process
FDA 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 in commerce: 2,585 units
Distribution: Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
Product codes and lots: Lot Number: 20105869 and 20111254

Product code DYB

K955785Class IITs Percutaneous Arterial/venus Catheter Intro SetC.R. Bard, Inc. / cleared 1996-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)