Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

FDA device recall Z-2405-2026 · posted 2026-06-11 · Open, Classified

Recall details

Recalling firm

Abbott Medical

Reason for recall

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

Action taken

On May 12 Abbott issued a Urgent Medical Device Recall notification via sales representative. Abbott ask consignees to take the following actions: Abbott has developed updated Merlin PCS 3650 programmer software (v28.9.1 rev 1 or higher) that resolves this behavior. Beginning with this notification, your Abbott Representative will upgrade programmer software to this software version . Abbott's service representative will proved a attestation to acknowledge receipt of the notification and software update. Please share this notification with others in your organization, as appropriate.

Root cause

Software Design Change

Status

Open, Classified

Product code

PNJ

Quantity affected

11182 programs

Distribution

US Nationwide distribution including in the states of 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

Date initiated

2026-05-12

Date posted

2026-06-11

Location

Sylmar, CA