Z-3038-2011

Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT...

Name: Z-3038-2011 Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT...
Creator: Biosense Webster, Inc.
Published: 2011-04-29
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2011-04-29 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar Electrophysiology Catheter has been... on 2011-04-29. The reason FDA records is "The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version...". 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-3038-2011
Status: Terminated
Initiated: 2011-04-29
Posted: 2011-08-18
Terminated: 2012-10-12
Recalling firm: Biosense Webster Inc
Product: Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping of cardiac structures.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: The recall was expanded because between February and April 2011, Biosense Webster, Inc. notified customers that a voluntary Customer Notification had been Initiated due to the inaccessibility of the electronic version of the Instructions for Use (e-IFU) for the "10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue", Catalog Number 0128709, through the J&J Gateway (i.e., e-IFU websi
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Biosense Webster sent an "URGENT FIELD SAFETY NOTICE" letter dated April 29, 2011 to all affected customers. The letter describes the product, problem, and the action taken by the firm. The letter notifies and advises customers that the updated IFUs for ISMUS Catheter with Auto ID Technology and the Duo-Decapolar catheters have been released and posted on the e-IFU website as of April 22, 2011 and April 21, 2011. Customers were instructed to complete the Acknowledgement Form and return the form to Biosense. Customers with questions or require additionial information were instructed to contact their Biosense Webster representative.
Quantity in commerce: 1530 units
Distribution: Nationwide Distribution
Product codes and lots: Not available

Product code DRF

K953768Class IICordis Webster A20 Diagnostic Deflectable Tip CatheterCordis Webster, Inc. / cleared 1995-11-22

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)