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

Recalled August 10, 2022 · FDA recall Z-1495-2022 · St. Jude Medical, Cardiac Rhythm Management Division

Hazard

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. · FDA Class II

Units

29,996 programs

Sold at

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Description

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.

Product

Merlin PCS 3650 programmer Model 3330 software

Manufacturer(s)

St. Jude Medical, Cardiac Rhythm Management Division

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →