Recall Z-2405-2026
Abbott Medical · initiated May 12, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Codes / lots: Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
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.
FDA-determined cause: Software Design Change
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.
Details
- Recall number
- Z-2405-2026
- Initiated
- May 12, 2026
- Posted by FDA
- June 11, 2026
- Product code
- PNJ – Leadless Pacemaker
- Quantity
- 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, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. OUS: Not provided yet
- Recalling firm
- Abbott Medical, Sylmar, CA