Abbott Medical — Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
⚠️ Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 12, 2026
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
What's affected?
- Product
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Brand
- Abbott Medical
- Lot code
- Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
Additional details
Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11182 programs.
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