Z-2405-2026 Class II Ongoing
FDA device recall Z-2405-2026 was initiated by Abbott Medical on May 12, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 11182 programs.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- May 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11182 programs
Product Description
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
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.
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
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)