Merlin recallZ-2405-2026 · Abbott Medical · initiated May 12, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-2405-2026
- Status
- Open, Classified
- Initiated by the company
- May 12, 2026
- Posted by the FDA
- Jun 11, 2026
- Recalling firm
- Abbott Medical
- Quantity
- 11182 programs
- Product code
- PNJ
- FDA submissions
- P150035
- 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 description
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Code information (models, lots, serial numbers)
Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Merlin™ 3330St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)6 recalls0 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under P150035 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Aveir™ LSP112VSt. Jude Medical, Inc. · Leadless pacemaker2 recalls73 deaths1,626 reports
- Aveir™ LSP202VSt. Jude Medical, Inc. · Leadless pacemaker1 recall39 deaths1,214 reports
- Aveir™ LSP201ASt. Jude Medical, Inc. · Leadless pacemaker15 deaths1,163 reports
- AVEIR™ LSP203ASt. Jude Medical, Inc. · Leadless pacemaker6 deaths440 reports
- Aveir™ LSCD201St. Jude Medical, Inc. · Leadless pacemaker21 deaths321 reports
- Aveir™ LSCD111St. Jude Medical, Inc. · Leadless pacemaker49 deaths248 reports
- Aveir™ LSL02St. Jude Medical, Inc. · Leadless pacemaker27 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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