Z-2664-2011

ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The...

Name: Z-2664-2011 ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The...
Creator: Biosense Webster, Inc.
Published: 2011-05-23
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2011-05-23 / Terminated

FDA source

Biosense Webster, Inc. began a recall of ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheters are indicated for multiple electrode... on 2011-05-23. The reason FDA records is "The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2664-2011
Status: Terminated
Initiated: 2011-05-23
Posted: 2011-06-27
Terminated: 2012-10-12
Recalling firm: Biosense Webster Inc
Product: ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.
FDA root cause: Pending
Action: Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.
Quantity in commerce: 429 units (333 in US)
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore
Product codes and lots: Catalog # D7R20P14CT

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)