Pulse Generator recallZ-0052-04 · St Jude Medical · initiated Jul 31, 2003
Terminated All recalls posted in October 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St Jude Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0052-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 31, 2003
- Posted by the FDA
- Oct 24, 2003
- Recalling firm
- St Jude Medical
- Quantity
- 775
- Product code
- DXY
- FDA submissions
- P880086
- Distribution
- Nationwide and to four VA Medical Centers in IA and MO.
Product description
Pulse Generator
Code information (models, lots, serial numbers)
Integrity ADx DR Model 5360 & 5366 Identity ADx DR model 5286, 5380, 5386 &5480 Verity ADx DR 5256, 5356 & 5456
Other devices under the same FDA submission
38 devices cleared under P880086 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Assurity™ PM2240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall84 deaths4,076 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Zephyr™ XL DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable24 deaths944 reports
- Assurity™ PM1240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall20 deaths306 reports
- Victory™ 5816St. Jude Medical, Inc. · implantable pacemaker Pulse-generator5 deaths347 reports
- Endurity™ PM2160St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall2 deaths237 reports
- Zephyr® DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable9 deaths219 reports
- Accent™ DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable20 deaths214 reports
- Accent™ SR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable12 deaths164 reports
- Zephyr™ XL SRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable2 deaths161 reports
- Assurity™ PM2260St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall109 reports
- Identity™ 5386St. Jude Medical, Inc. · implantable pacemaker Pulse-generator3 deaths154 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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