FDA recall Z-2405-2026

Abbott Medical · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2026-05-12
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sylmar, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2026