Recall Z-0753-2025 ยท PNJ Leadless Pacemaker
Abbott Medical
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
| Date | Dec 23, 2024 (initiated Nov 21, 2024) |
| Status | Open, Classified |
| Reason | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing. |
| Root cause | Under Investigation by firm |
| Action | On 11/21/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via in person or certified mail to customers informing them that Abbott is aware of a programmer software anomaly that may incorrectly reprogram a ventricular Aveir leadless pacer during the Finalize the New LP ( Finalization ) step of the implant process for an AVEIR DR Leadless Pacemaker (LP) System. This can occur during an upgrade from an AVEIR VR to an AVEIR DR system or during a new AVEIR DR system implant. If telemetry is lost during a small window (<2 seconds) during Finalization of the Right Atrial (RA) LP after |
| Quantity | 7295 programmers |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA, WI, and WV. The countries of Austria, Belgium, Canada, Denmar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.