- Recalling firm
- Abbott Medical
- 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.
- Affected products (lot / model / serial)
- Programmer Model 3650; Software Model 3330; GTIN 05414734509725; Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
- Units affected
- 11182 programs
- 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
- Firm location
- Sylmar, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2405-2026
- Recall initiated
- May 12, 2026
- FDA classification date
- June 11, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98963
- Last updated on HTM Vibe
- July 23, 2026