The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming syst

FDA device recall Z-0753-2025 · posted 2024-12-23 · Open, Classified

Recall details

Recalling firm

Abbott Medical

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.

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.).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PNJ

Quantity affected

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,

Date initiated

2024-11-21

Date posted

2024-12-23

Location

Sylmar, CA