St. Jude Medical, Cardiac Rhythm Management Division recalls Merlin 2 PCS MER37000 programmer Model MER3400 software

Recall date

June 17, 2022

Source

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

Recall number

Z-1496-2022

FDA classification

Class II

Brand / firm

St. Jude Medical, Cardiac Rhythm Management Division

Sold / distributed

US: 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 PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: ALBANIA ALGERIA ANGOLA Argentina ARMENIA Australia AUSTRIA AZERBAIJAN BAHRAIN Bangladesh BELGIUM BENIN BOLIVIA BOSNIA-HERZ.…

Why it was recalled

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

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 2 PCS MER37000 programmer Model MER3400 software