St. Jude Medical, Cardiac Rhythm Management Division 2022-08-10 Health serious FDA
Health · FDA · Recall #FDA-Z-1496-2022
Merlin 2 PCS MER37000 programmer Model MER3400 software Recall
Issued August 10, 2022 · St. Jude Medical, Cardiac Rhythm Management Division
In August 2022, St. Jude Medical, Cardiac Rhythm Management Division recalled the Merlin 2 PCS MER37000 programmer Model MER3400 software, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Merlin 2 PCS MER37000 programmer Model MER3400 software right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact St. Jude Medical, Cardiac Rhythm Management Division to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- St. Jude Medical, Cardiac Rhythm Management Division
- Category
- Health
- Recall date
- August 10, 2022
- Units affected
- Not reported
- Sold at
- 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 U
- Recall number
- FDA-Z-1496-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- St. Jude Medical, Cardiac Rhythm Management Division has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.