Z-1010-03

Pulsar Max II Multiprogrammable Pacemaker, Model 1181

Name: Z-1010-03 Pulsar Max II Multiprogrammable Pacemaker, Model 1181
Creator: Guidant Corp-Cpi Division
Published: 2003-06-23
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-06-23 / Terminated

FDA source

Guidant Corp-Cpi Division began a recall of Pulsar Max II Multiprogrammable Pacemaker, Model 1181 on 2003-06-23. The reason FDA records is "Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1010-03
Status: Terminated
Initiated: 2003-06-23
Posted: 2003-07-15
Terminated: 2004-07-02
Recalling firm: Boston Scientific Corporation
Product: Pulsar Max II Multiprogrammable Pacemaker, Model 1181
Product code: DXY Implantable Pacemaker Pulse-Generator
Reason for recall: Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
FDA root cause: Other
Action: On June 23, 2003, sales representatives began retrieving any recalled pacemakers, which were not implanted. For implanted pacemakers, an 'Important Patient Management Information' letter, dated June 23, 2003, was sent to physicians recommending that pacemaker-dependent patients, with the potentially affected pacemakers, be scheduled for exams to check for proper pacemaker performance using a programmer.
Quantity in commerce: 1 pacemaker
Distribution: Nationwide in the United States and worldwide.
Product codes and lots: Serial number 811798

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)