Pulse Generator
FDA Recall Z-0052-04 · Posted 2003-10-24
Recalling FirmSt Jude Medical
Recall StatusTerminated
Product CodeDXY
Date Initiated2003-07-31
Date Terminated2004-03-26
Product Quantity775
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and to four VA Medical Centers in IA and MO.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.