Pulse Generator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pulse Generator
Lot Codes / Batch Numbers
Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456
Products Sold
Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456
A medical device manufacturer is recalling Pulse Generator due to Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026