Z-0890-03

Insignia Plus Multiprogrammable Pacemaker, DDD Model 985

Name: Z-0890-03 Insignia Plus Multiprogrammable Pacemaker, DDD Model 985
Creator: Guidant Corp-Cpi Division
Published: 2003-05-06
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-05-06 / Terminated

FDA source

Guidant Corp-Cpi Division began a recall of Insignia Plus Multiprogrammable Pacemaker, DDD Model 985 on 2003-05-06. The reason FDA records is "In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0890-03
Status: Terminated
Initiated: 2003-05-06
Posted: 2003-05-29
Terminated: 2005-11-18
Recalling firm: Boston Scientific Corporation
Product: Insignia Plus Multiprogrammable Pacemaker, DDD Model 985
Product code: DXY Implantable Pacemaker Pulse-Generator
Reason for recall: In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
FDA root cause: Other
Action: An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
Distribution: Nationwide in the United States and worldwide.
Product codes and lots: All Serial numbers

Product code DXY

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)