Z-1647-2012

EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in...

Name: Z-1647-2012 EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in...
Creator: Biosense Webster, Inc.
Published: 2007-12-15
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2007-12-15 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation on 2007-12-15. The reason FDA records is "The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1647-2012
Status: Terminated
Initiated: 2007-12-15
Posted: 2012-05-22
Terminated: 2012-05-23
Recalling firm: Biosense Webster Inc
Product: EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: The firm, Biosense Webster, sent a "Medical Device-Voluntary Field Removal" letter dated December 17, 2007 to its customer. The letter identified the product, problem and an action to be taken. The customer was instructed to complete and return the Product Voluntary Field Removal Certification Form via fax to Quality Compliance at (909) 839-7207or mail using the enclosed self-addressed stamped envelope. If you have additional questions, please follow up with your local Biosense Webster representative.or contact Customer Service at (909) 839-8500.
Quantity in commerce: 1 unit
Distribution: Nationwide distribution: CA only.
Product codes and lots: Lot Number: 13140790A

Product code DRF

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)