Abbott Medical: Leadless Pacemaker
Recall Summary Abbott Medical is recalling Merlin Patient Care System software used with leadless pacemakers because a software malfunction may prevent the programmer from stopping a pacing capture threshold test. The affected software includes Merlin PCS 3650 programmer Model 3330 versions. This recall affects devices distributed nationwide across the United States.
- Recalling firm
- Abbott Medical
- Product
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Reason
- Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/daad8deb-60b3-4204-ad30-56db67b47fce