Z-2405-2026Class II

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

Name: Z-2405-2026 Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Creator: Abbott Medical
Published: 2026-05-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2026-05-12 / Open, Classified / root cause: software

FDA source

Abbott Medical began a recall of Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software on 2026-05-12. FDA classified it as Class II and gives the reason as "Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2405-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-12
Posted: 2026-06-11
Recalling firm: Abbott Medical
Product: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Product code: PNJ Leadless Pacemaker
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.
Root cause tag: software
FDA root cause: Software Design Change
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.
Quantity in commerce: 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
Product codes and 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2405-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2405-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-11

Product code PNJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)