Reported Jun 28, 2023 · Ongoing
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; 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 DF1Model Number DTPC2Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178260
- Lot Serial Numbers
97 of 97 codes
RTT600077SRTT600166SRTT600169SRTT600064SRTT600083SRTT600071SRTT600042SRTT600028SRTT600107SRTT600034SRTT600421SRTT600432SRTT600434SRTT600574SRTT600161SRTT600054SRTT600160SRTT600231SRTT600431SRTT600045SRTT600165SRTT600022SRTT600062SRTT600091SRTT600195SRTT600430SRTT600437SRTT600438SRTT600125SRTT600533SRTT600427SRTT600481SRTT600111SRTT600128SRTT600040SRTT600066SRTT600046SRTT600573SRTT600322SRTT600076SRTT600024SRTT600134SRTT600150SRTT600531SRTT600047SRTT600086SRTT600220SRTT600059SRTT600063SRTT600426SRTT600530SRTT600075SRTT600095SRTT600149SRTT600537SRTT600541SRTT600546SRTT600549SRTT600550SRTT600552S
- Lot Serial Numbers
308 of 308 codes
RTT600985SRTT600411SRTT600879SRTT600925SRTT601085SRTT600918SRTT600632SRTT600977SRTT600367SRTT600456SRTT600459SRTT600389SRTT600323SRTT600351SRTT600453SRTT600356SRTT600360SRTT600377SRTT600558SRTT600577SRTT600547SRTT600314SRTT600334SRTT600522SRTT600592SRTT600608SRTT600609SRTT600601SRTT600630SRTT600631SRTT600663SRTT600668SRTT600669SRTT600967SRTT600521SRTT600948SRTT600968SRTT600969SRTT600315SRTT600338SRTT600512SRTT600346SRTT600350SRTT600443SRTT600482SRTT600595SRTT600606SRTT600329SRTT600375SRTT600318SRTT600310SRTT600133SRTT600397SRTT600518SRTT600898SRTT600307SRTT600414SRTT600452SRTT600548SRTT600587S
- Amount recalled
- 404 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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