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FDA-Device2026-06-17Class IIPROCESSING DEFECT

Abbott Merlin PCS 3650 pacemaker programmer software recalled for communication malfunction during threshold testing

Abbott
OTHERNationwide distribution

Abbott Merlin PCS 3650 programmer software recalled for test termination malfunction

Abbott's Merlin PCS 3650 programmer software (versions 25.0.1 through 28.7.1) may malfunction during pacing capture threshold tests on pacemakers. When this occurs, the programmer may fail to successfully send the command to stop the test.

  • If you use or operate a Merlin PCS 3650 programmer, contact Abbott Medical for software guidance or updates
  • Do not perform pacing capture threshold tests until you receive updated instructions from Abbott
  • Contact your device representative or Abbott technical support for more information
Hazard

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

Sold states
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
Affected count
11182 programs
Manufactured in
15900 Valley View Ct, N/A, Sylmar, CA, United States
Products
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

Official notice

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

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