Z-0076-04

Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software

Name: Z-0076-04 Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software
Creator: Biotronik Inc
Published: 2003-09-24
License: https://open.fda.gov/license/

BIOTRONIK AG / initiated 2003-09-24 / Terminated

FDA source

Biotronik Inc began a recall of Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software on 2003-09-24. The reason FDA records is "Potential for early depletion of Implantable Cardioverter Defibrillator battery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0076-04
Status: Terminated
Initiated: 2003-09-24
Posted: 2003-10-31
Terminated: 2005-02-17
Recalling firm: BIOTRONIK AG
Product: Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: Potential for early depletion of Implantable Cardioverter Defibrillator battery.
FDA root cause: Other
Action: Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices.
Quantity in commerce: 794 devices
Distribution: The firm distributes to physicians located throughout the US.
Product codes and lots: Serial Numbers: 7811xxxx

Product code LWS

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)