Reported Jun 28, 2023 · Ongoing
CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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 DTMB2Q1 AMPLIA MRI QUAD OUS DF1Model Number DTMB2Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837638
- Lot Serial Numbers
2,714 of 2,714 codes
RPP602125SRPP602593SRPP603699SRPP602902SRPP602417SRPP601873SRPP602956SRPP601533SRPP603620SRPP600808SRPP603725SRPP602431SRPP602451SRPP602452SRPP602460SRPP602737SRPP602741SRPP602778SRPP602780SRPP603298SRPP603299SRPP603300SRPP603303SRPP603679SRPP603685SRPP603686SRPP603690SRPP603812SRPP603814SRPP603815SRPP603819SRPP603821SRPP603822SRPP603825SRPP603832SRPP603833SRPP603840SRPP603843SRPP603844SRPP603847SRPP603848SRPP603849SRPP603852SRPP603855SRPP603859SRPP603860SRPP603861SRPP603862SRPP603863SRPP603868SRPP603870SRPP603871SRPP602254SRPP603326SRPP601331SRPP601392SRPP602961SRPP601050SRPP602800SRPP603221S
- Amount recalled
- 4767 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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