Recall Z-0753-2025
Abbott Medical · initiated November 21, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Programmer Model Number: 3650 UDI-DI code: 05414734509725 Software Version Number / Serial Numbers: 28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2 12050154 28.0.1 REV 2 12051352 28.0.1 REV 2 12051615 28.0.1 REV 2 12056133 28.0.1 REV 2 12713 28.0.1 REV 2 14655 28.0.1 REV 2 23324 28.0.1 REV 2 24050 28.0.1 REV 2 12042174 28.0.1 REV 2 12042239 28.0.1 REV 2 12048730 28.0.1 REV 2 11959 28.0.1 REV 2 16116 28.0.1 REV 2 16571 28.0.1 REV 2 27499 28.0.1 REV 2 12056125 28.0.1 REV 2 15378 28.0.1 REV 2 18041 28.0.1 REV 2 27164 28.0.1 REV 2 12045425 28.0.1 REV 2 12045483 28.0.1 REV 2 12870 28.0.1 REV 2 14910 28.0.1 REV 2 18143 28.0.1 REV 2 21904 28.0.1 REV 2 23317 28.0.1 REV 2 12043799 28.0.1 REV 2 12044806 28.0.1 REV 2 12055973 28.0.1 REV 2 24842 28.0.1 REV 2 12040739 28.0.1 REV 2 12042686 28.0.1 REV 2 12044212 28.0.1 REV 2 12045527 28.0.1 REV 2 12052141 28.0.1 REV 2 12055384 28.0.1 REV 2 12052537 28.0.1 REV 2 19660 28.0.1 REV 2 21099 28.0.1 REV 2 24610 28.0.1 REV 2 30022 28.0.1 REV 2 12044540 28.0.1 REV 2 12047076 28.0.1 REV 2 12053304 28.0.1 REV 2 12706 28.0.1 REV 2 20207 28.0.1 REV 2 20933 28.0.1 REV 2…
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 the Right Ventricular (RV) LP is Finalized, the programmer software anomaly configures the RV LP to incorrectly behave as an RA LP. If this occurs, the Merlin PCS 3650 Programmer displays a Loss of telemetry detected window, and there is no pacing. Additionally, atrial sense markers coincident to intrinsic QRS complexes may be observed. Subsequent attempts to finalize the device will continue to result in a Loss of telemetry detected window. In all cases where this occurred, full functionality, including ability to finalize the device and restore pacing, was reinstated through Abbott Technical Services intervention. Action Abbott has Taken: Currently available Merlin" PCS 3650 programmer software (version 28.2.1 rev 2) prevents this issue. An Abbott Representative will upgrade your programmer software and work with customer to ensure use of version 28.2.1 rev 2 or greater as it eliminates this issue. A list of Abbott advisories is available at https://www.cardiovascular.abbott/us/en/hcp/product-advisories.html. any questions about this notice, contact Abbott Technical Services at 1-800-722-3774 (U.S.).
Details
- Recall number
- Z-0753-2025
- Initiated
- November 21, 2024
- Posted by FDA
- December 23, 2024
- Product code
- PNJ – Leadless Pacemaker
- 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, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Kuwait, Netherlands, Norway, Poland…
- Recalling firm
- Abbott Medical, Sylmar, CA