medical Class II Updated 2018-07-11

St Jude Medical Inc. recalls Merlin PCS Programmer Software: 3330 The Merlin PCS progr

Recalled Product

Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.


Hazard / Issue

The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Versions: 24.0.1 rev 1
View official government recall

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