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

Recall date

March 10, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0964-2022

FDA classification

Class II

Brand / firm

St. Jude Medical, Cardiac Rhythm Management Division

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentin…

Why it was recalled

Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Merlin PCS 3650 programmer Model 3330 software