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Open, Classified

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

FDA Recall Z-2405-2026 · Posted 2026-06-11

Recalling FirmAbbott Medical
Recall StatusOpen, Classified
Product CodePNJ
Date Initiated2026-05-12
Product Quantity11182 programs

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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