Discovery II Multiprogrammable Pacemaker, Model 0981
FDA device recall Z-1012-03 · posted 2003-07-15 · Terminated
Recall details
- Recalling firm
- Guidant Corp-Cpi Division
- Reason for recall
- Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
- Action taken
- 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
- Status
- Terminated
- Product code
- DXY
- Quantity affected
- 12 pacemakers
- Distribution
- Nationwide in the United States and worldwide.
- Date initiated
- 2003-06-23
- Date posted
- 2003-07-15
- Date terminated
- 2004-07-02
- Location
- St Paul, MN
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