CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report

Merlin" Patient Care System (PCS) recalled by Abbott Medical

Abbott Medical is recalling Merlin" Patient Care System (PCS), distributed nationwide in the US. The recall was initiated on 12 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProgrammer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)

Quantity recalled11182 programs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2405-2026
FDA event ID: 98963
Recalling firm: Abbott Medical, Sylmar, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 May 2026
FDA classified: 11 Jun 2026
Reported: 17 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

12 May 2026	Recall initiated by company
11 Jun 2026	Classified by FDA	+30 days
17 Jun 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is Merlin" Patient Care System (PCS) recalled?

Yes. Abbott Medical recalled Merlin" Patient Care System (PCS) on 12 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2405-2026.

Why was it recalled?

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

Which lots are affected?

Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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23 Apr 2025Device	CLASS II	Aveir DR Leadless Pacemaker (LP) Ventricular Device recalled	Abbott Medical	Temperature Abuse	Nationwide
4 Dec 2024Device	CLASS III	Merlin@home with the MerlinOnDemand capability Transmitter recalled	Abbott Medical	Device Malfunction	Nationwide
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