Pulse Generator
FDA device recall Z-0052-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- St Jude Medical
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXY
- Quantity affected
- 775
- Distribution
- Nationwide and to four VA Medical Centers in IA and MO.
- Date initiated
- 2003-07-31
- Date posted
- 2003-10-24
- Date terminated
- 2004-03-26
- Location
- Sylmar, CA
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