Reported Jun 28, 2023 · Ongoing
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; 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 DTMB2D1 AMPLIA MRI OUS DF1Model Number DTMB2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837645
- Lot Serial numbers
2,714 of 2,714 codes
RPQ605053SRPQ606292SRPQ605067SRPQ605093SRPQ601699SRPQ605875SRPQ605881SRPQ601451SRPQ602698SRPQ605503SRPQ606300SRPQ601185SRPQ601351SRPQ601948SRPQ601950SRPQ602093SRPQ602202SRPQ602212SRPQ602402SRPQ602403SRPQ602595SRPQ602960SRPQ602961SRPQ602985SRPQ603049SRPQ603082SRPQ603318SRPQ603408SRPQ603450SRPQ605289SRPQ606079SRPQ603112SRPQ603355SRPQ603428SRPQ604101SRPQ604644SRPQ602479SRPQ603775SRPQ604354SRPQ604567SRPQ605754SRPQ605514SRPQ605535SRPQ603729SRPQ605540SRPQ603758SRPQ604571SRPQ605118SRPQ602683SRPQ602692SRPQ602715SRPQ603495SRPQ603504SRPQ603555SRPQ603644SRPQ603647SRPQ604572SRPQ604621SRPQ604622SRPQ604684S
- Amount recalled
- 6536 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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