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U.S. Department of Health and Human Services

Class 2 Device Recall St. Jude Medical

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  Class 2 Device Recall St. Jude Medical see related information
Date Initiated by Firm July 31, 2003
Date Posted October 24, 2003
Recall Status1 Terminated 3 on March 26, 2004
Recall Number Z-0052-04
Recall Event ID 27045
PMA Number P880086 
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
Product Pulse Generator
Code Information Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456
Recalling Firm/
St Jude Medical
15900 Valley View Court
Sylmar CA 91342
For Additional Information Contact Nes Kusnierz
Manufacturer 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.
FDA Determined
Cause 2
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.
Quantity in Commerce 775
Distribution Nationwide and to four VA Medical Centers in IA and MO.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DXY and Original Applicant = Abbott Medical