Reported Jun 28, 2023 · Ongoing
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
CRTD DTMA2D1 CLARIA MRI OUS DF1Model Number DTMA2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837621
- Lot Serial Numbers
2,714 of 2,714 codes
RPO604357SRPO603344SRPO603999SRPO603613SRPO602588SRPO603485SRPO603586SRPO603863SRPO601733SRPO603715SRPO601235SRPO601389SRPO601698SRPO601771SRPO602006SRPO602325SRPO602359SRPO602456SRPO602547SRPO602630SRPO602667SRPO602723SRPO602912SRPO602956SRPO603277SRPO603281SRPO603474SRPO603611SRPO604037SRPO604118SRPO604253SRPO604259SRPO604282SRPO604326SRPO604369SRPO604405SRPO604406SRPO603440SRPO603702SRPO603703SRPO604049SRPO604050SRPO604051SRPO604073SRPO603075SRPO601669SRPO601697SRPO601763SRPO602062SRPO602101SRPO602494SRPO602703SRPO602722SRPO603071SRPO603199SRPO603211SRPO603337SRPO603351SRPO603374SRPO603645S
- Amount recalled
- 3570 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Using this product could cause serious injury, illness or death — stop using it now.
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