St Jude Medical Inc. recalls Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to supp…

Recall date

April 16, 2018

Source

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

Recall number

Z-2335-2018

FDA classification

Class II

Brand / firm

St Jude Medical Inc.

Sold / distributed

U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,

Why it was recalled

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.

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 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.