Z-1437-04

Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035...

Name: Z-1437-04 Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035...
Creator: Biosense Webster, Inc.
Published: 2004-08-16
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2004-08-16 / Terminated

FDA source

Biosense Webster, Inc. began a recall of Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S... on 2004-08-16. The reason FDA records is "Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1437-04
Status: Terminated
Initiated: 2004-08-16
Posted: 2004-09-02
Terminated: 2005-03-31
Recalling firm: Biosense Webster Inc
Product: Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q.
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
FDA root cause: Other
Action: Sales Representative to provide letter to each of the 25 US customers explaining the action. Sales Representatives will remove any affected product from customers inventory. Certification records will be completed for each customer confirming the removal action. International affiliates to conduct similar actions.
Quantity in commerce: 848
Distribution: Nationwide and Japan, Europe, & Uruguay
Product codes and lots: 112 lots

Product code DRF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)