medical Class II Updated 2022-08-10

St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin PCS 3650 programmer Model 3330 software

Recalled Product

Merlin PCS 3650 programmer Model 3330 software


Hazard / Issue

There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

Issued by

FDA

Affected States: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Lot/Code Info: Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725
View official government recall

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