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Recall Observatory FDA recall evidence

Device product

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

Z-2405-2026

May 12, 2026

Class II

Product summary

Firm
Abbott Medical
Event
Event 98963
Status
Ongoing
Classification
Class II
Quantity
11182 programs
Official record key
device-enforcement:Z-2405-2026

Official wording

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

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

Distribution pattern: 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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software malfunction