Z-0052-04

Pulse Generator

Name: Z-0052-04 Pulse Generator
Creator: St Jude Medical
Published: 2003-07-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-07-31 / Terminated

FDA source

St Jude Medical began a recall of Pulse Generator on 2003-07-31. The reason FDA records is "Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0052-04
Status: Terminated
Initiated: 2003-07-31
Posted: 2003-10-24
Terminated: 2004-03-26
Recalling firm: Abbott Medical
Product: Pulse Generator
Product code: DXY Implantable Pacemaker Pulse-Generator
Reason for recall: Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
FDA root cause: Other
Action: Sales Representatives will personally contact the physicians, explain the situation, leave a technical memo and a list of implanted patients for the doctor to follow-up with. The ''Dear Doctor'' letter to accompany the representatives is dated 7/31/2003. Instruments not implanted will be returned for reprocessing.
Quantity in commerce: 775
Distribution: Nationwide and to four VA Medical Centers in IA and MO.
Product codes and lots: Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456

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)