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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 Medicalsee related information
Date Initiated by FirmJuly 31, 2003
Date PostedOctober 24, 2003
Recall Status1 Terminated 3 on March 26, 2004
Recall NumberZ-0052-04
Recall Event ID 27045
PMA NumberP880086 
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
ProductPulse 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/
Manufacturer
St Jude Medical
15900 Valley View Court
Sylmar CA 91342
For Additional Information ContactNes Kusnierz
818-362-6822
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
Other
ActionSales 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 Commerce775
DistributionNationwide and to four VA Medical Centers in IA and MO.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = DXY
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