Recall Z-1495-2022 ยท DXY Implantable Pacemaker Pulse-Generator
St. Jude Medical, Cardiac Rhythm Management Division
Merlin PCS 3650 programmer Model 3330 software
| Date | Jun 17, 2022 |
| Status | Open, Classified |
| Reason | There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. |
| Root cause | Software design |
| Action | On June 16, 2022 Abbott issued a "Medical Device Correction" via: XXXX to affected consignees. The customer notification ask consignees to take the following action: 1. Prophylactic device replacement is not recommended, as device functionality, actual longevity, and ERI indicator are not impacted (device functionality remains normal and within specifications). 2. Routine follow-up should remain as per local standard of care and clinical protocol, and ERI should continue to serve as an indicator of the need for device replacement scheduling. 3. Please direct any questions about device lon |
| Quantity | 29,996 programs |
| Distribution | US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: ALBANIA ALGERIA ANGOLA Argentina ARMENIA Australia AUSTRIA AZERBAIJAN BAHRAIN Bangladesh BELGIUM BENIN BOLIVIA BOSNIA-HERZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.