Reported Jun 28, 2023 · Ongoing
CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; 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 CROME HF QUAD MRI IS4 DF4Model Number DTPC2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178253
- Lot Serial Numbers
859 of 859 codes
RTS600109SRTS600115SRTS600751SRTS600754SRTS600962SRTS600827SRTS600976SRTS600761SRTS600116SRTS600128SRTS600174SRTS600280SRTS600285SRTS600674SRTS600094SRTS600271SRTS600277SRTS600961SRTS600987SRTS601452SRTS600164SRTS600168SRTS600203SRTS600209SRTS600222SRTS600375SRTS600636SRTS600652SRTS600734SRTS600800SRTS600876SRTS600127SRTS600189SRTS600170SRTS600171SRTS600251SRTS600459SRTS600460SRTS600464SRTS600537SRTS600608SRTS600792SRTS601104SRTS601108SRTS600087SRTS600091SRTS601032SRTS600079SRTS600080SRTS600081SRTS600083SRTS600119SRTS600161SRTS600255SRTS600258SRTS600261SRTS600316SRTS600322SRTS600418SRTS600812S
- Lot Serial numbers
1,284 of 1,284 codes
RTS602089SRTS602629SRTS602219SRTS602229SRTS602122SRTS602937SRTS602798SRTS603142SRTS602680SRTS603044SRTS603140SRTS603128SRTS603107SRTS602713SRTS603098SRTS602450SRTS601783SRTS603094SRTS601887SRTS602462SRTS602504SRTS600293SRTS600358SRTS600846SRTS600504SRTS601156SRTS601157SRTS600532SRTS600541SRTS601206SRTS600833SRTS601396SRTS602818SRTS601695SRTS601710SRTS601165SRTS602866SRTS603041SRTS600490SRTS600563SRTS600564SRTS601049SRTS601465SRTS601481SRTS602087SRTS602695SRTS601038SRTS601675SRTS602472SRTS601842SRTS602863SRTS600311SRTS600663SRTS601873SRTS601888SRTS602732SRTS600499SRTS601203SRTS601855SRTS602163S
- Amount recalled
- 2142 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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