Reported Jun 28, 2023 · Ongoing
CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; 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 MRI IS1 DF1Model Number DTPC2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178307
- Lot Serial numbers
196 of 196 codes
RTX600076SRTX600084SRTX600139SRTX600148SRTX600114SRTX600308SRTX600386SRTX600327SRTX600334SRTX600372SRTX600046SRTX600048SRTX600066SRTX600108SRTX600261SRTX600345SRTX600586SRTX600382SRTX600388SRTX600064SRTX600069SRTX600096SRTX600377SRTX600360SRTX600581SRTX600158SRTX600306SRTX600713SRTX600100SRTX600319SRTX600594SRTX600720SRTX600727SRTX600045SRTX600153SRTX600157SRTX600326SRTX600081SRTX600146SRTX600055SRTX600058SRTX600143SRTX600314SRTX600323SRTX600332SRTX600344SRTX600693SRTX600307SRTX600310SRTX600317SRTX600588SRTX600705SRTX600072SRTX600095SRTX600147SRTX600695SRTX600698SRTX600309SRTX600792SRTX600167S
- Lot Serial Numbers
267 of 267 codes
RTX600495SRTX600869SRTX600878SRTX600868SRTX600848SRTX600890SRTX600844SRTX600472SRTX600624SRTX600628SRTX600629SRTX600630SRTX600730SRTX600773SRTX600832SRTX600836SRTX600989SRTX600850SRTX600978SRTX600625SRTX600840SRTX600574SRTX600845SRTX600977SRTX600834SRTX600900SRTX600508SRTX600564SRTX600967SRTX600745SRTX600896SRTX600626SRTX600517SRTX600827SRTX600603SRTX600490SRTX600621SRTX600863SRTX600941SRTX600887SRTX600936SRTX600468SRTX600469SRTX600477SRTX600478SRTX600491SRTX600554SRTX600604SRTX600607SRTX600620SRTX600631SRTX600829SRTX600854SRTX600163SRTX600249SRTX600492SRTX600973SRTX600088SRTX600179SRTX600269S
- Amount recalled
- 462 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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