Z-1328-04

Stockert 70 Radio Frequency Ablation Generator

Name: Z-1328-04 Stockert 70 Radio Frequency Ablation Generator
Creator: Biosense Webster, Inc.
Published: 2004-07-16
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2004-07-16 / Terminated

FDA source

Biosense Webster, Inc. began a recall of Stockert 70 Radio Frequency Ablation Generator on 2004-07-16. The reason FDA records is "Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1328-04
Status: Terminated
Initiated: 2004-07-16
Posted: 2004-08-07
Terminated: 2012-05-07
Recalling firm: Biosense Webster Inc
Product: Stockert 70 Radio Frequency Ablation Generator
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
FDA root cause: Other
Action: Customers were instructed to suspend use of the generators with software version 1.033 until they are upgraded with version 1.034B in a letter dated 7/15/2004. Firm issued a second letter on 9/17/04 for a software error discovered in-house during the upgrade. It instructs a workaround solution to prevent unwanted activity of the catheter.
Quantity in commerce: unknown, not stated.
Distribution: Nationwide
Product codes and lots: Al generators except with version 1.034B

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)