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Terminated

Pulsar Max II Multiprogrammable Pacemaker, Model 1180

FDA Recall Z-1009-03 · Posted 2003-07-15

Recalling FirmGuidant Corp-Cpi Division
Recall StatusTerminated
Product CodeDXY
Date Initiated2003-06-23
Date Terminated2004-07-02
Product Quantity12 pacemakers

Reason for Recall

Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide in the United States and worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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