FDAFDA · Food and drugs·Recall number Z-2405-2026
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Published June 17, 2026 · Recall initiated: May 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Medical
- Distributor
- 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
- Lot
- Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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