Reported Jun 28, 2023 · Ongoing
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; 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?
ICD CROME DR MRI IS1 DF1Model Number DDPC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178413
- Lot Serial Numbers
111 of 111 codes
RSP600249SRSP600057SRSP600253SRSP600085SRSP600014SRSP600150SRSP600148SRSP600089SRSP600091SRSP600114SRSP600189SRSP600210SRSP600394SRSP600130SRSP600216SRSP600256SRSP600386SRSP600149SRSP600245SRSP600066SRSP600068SRSP600069SRSP600083SRSP600112SRSP600132SRSP600136SRSP600404SRSP600076SRSP600731SRSP600954SRSP600955SRSP600953SRSP600070SRSP600145SRSP600157SRSP600200SRSP600226SRSP600082SRSP600139SRSP600141SRSP600152SRSP600163SRSP600074SRSP600732SRSP600204SRSP600369SRSP600726SRSP600748SRSP600048SRSP600080SRSP600363SRSP600396SRSP600397SRSP600408SRSP600444SRSP600544SRSP600335SRSP600383SRSP600400SRSP600808S
- Lot Serial Numbers
377 of 377 codes
RSP600738SRSP601022SRSP600759SRSP600761SRSP600976SRSP600984SRSP601035SRSP601038SRSP600783SRSP600912SRSP600930SRSP601015SRSP601085SRSP601112SRSP601105SRSP600988SRSP600871SRSP601089SRSP600824SRSP600100SRSP600155SRSP600517SRSP600627SRSP600845SRSP600523SRSP600639SRSP600861SRSP600654SRSP600575SRSP600521SRSP600609SRSP600614SRSP600640SRSP600650SRSP600742SRSP600616SRSP600513SRSP600151SRSP600641SRSP600649SRSP600850SRSP600860SRSP600651SRSP600520SRSP600618SRSP600837SRSP600794SRSP600179SRSP600594SRSP600741SRSP600524SRSP600648SRSP600143SRSP600753SRSP600056SRSP600061SRSP600064SRSP600171SRSP600172SRSP600543S
- Amount recalled
- 487 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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