Reported Jun 28, 2023 · Ongoing
CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; 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 COBALT HF MRI IS1 DF4Model Number DTPB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178215
- Lot Serial Numbers
2,591 of 2,591 codes
RTO600161SRTO600247SRTO601140SRTO601641SRTO602045SRTO602335SRTO602270SRTO600314SRTO601040SRTO601383SRTO600175SRTO600229SRTO600417SRTO600458SRTO600507SRTO600650SRTO601039SRTO602060SRTO603798SRTO600463SRTO601433SRTO601826SRTO601973SRTO602476SRTO601038SRTO601148SRTO601171SRTO601248SRTO602261SRTO601481SRTO600833SRTO601285SRTO601310SRTO601556SRTO600393SRTO602484SRTO600262SRTO600681SRTO601538SRTO600380SRTO600384SRTO601944SRTO602394SRTO602445SRTO600968SRTO601037SRTO601565SRTO600218SRTO601309SRTO601311SRTO601453SRTO603333SRTO600332SRTO600493SRTO601704SRTO601798SRTO601954SRTO601983SRTO602442SRTO601808S
- Lot Serial Numbers
120 of 120 codes
RTO602972SRTO602773SRTO603128SRTO603142SRTO603053SRTO601133SRTO602299SRTO603068SRTO603073SRTO603465SRTO600045SRTO601022SRTO601374SRTO601398SRTO601016SRTO603129SRTO600983SRTO603123SRTO602497SRTO602615SRTO602454SRTO602602SRTO603399SRTO603457SRTO601282SRTO601379SRTO603057SRTO603138SRTO603396SRTO603504SRTO603055SRTO602833SRTO603624SRTO603046SRTO602841SRTO602877SRTO603373SRTO601396SRTO603043SRTO602933SRTO602831SRTO602225SRTO601256SRTO601233SRTO601268SRTO601284SRTO601344SRTO602254SRTO602603SRTO603061SRTO603289SRTO603419SRTO604085SRTO603059SRTO600988SRTO600989SRTO601300SRTO601185SRTO601252SRTO603066S
- Amount recalled
- 2968 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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