Reported Jun 28, 2023 · Ongoing
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; 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 DTMC1D1 COMPIA MRI US DF1Model Number DTMC1D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837706
- Lot Serial Numbers
343 of 343 codes
RPW200770HRPW200730HRPW201054HRPW200583HRPW200593HRPW200970HRPW201002HRPW201095HRPW200917HRPW201040HRPW201026HRPW200661HRPW200981HRPW200665HRPW200741HRPW200743HRPW200908HRPW200971HRPW200600HRPW200635HRPW200638HRPW200652HRPW200657HRPW200660HRPW200761HRPW200800HRPW200803HRPW200822HRPW200827HRPW200714HRPW200809HRPW200548HRPW201023HRPW201103HRPW200575HRPW200794HRPW200807HRPW200994HRPW201055HRPW200630HRPW200659HRPW200904HRPW201079HRPW201171HRPW200578HRPW200695HRPW200621HRPW201015HRPW201084HRPW201151HRPW201153HRPW200590HRPW200938HRPW200582HRPW200847HRPW200870HRPW200683HRPW200685HRPW200754HRPW200852H
- Lot Serial Numbers
322 of 322 codes
RPW600177SRPW600267SRPW600059SRPW600341SRPW600418SRPW600064SRPW600173SRPW600395SRPW600018SRPW600292SRPW600381SRPW600342SRPW600352SRPW600356SRPW600317SRPW600405SRPW600306SRPW600319SRPW600273SRPW600281SRPW600146SRPW600062SRPW600041SRPW600140SRPW600162SRPW600265SRPW600307SRPW600073SRPW600068SRPW600070SRPW600074SRPW600151SRPW600175SRPW600314SRPW600030SRPW600086SRPW600123SRPW600165SRPW600023SRPW600225SRPW600275SRPW600194SRPW600339SRPW600340SRPW600017SRPW600099SRPW600348SRPW600211SRPW600268SRPW600244SRPW600313SRPW600338SRPW600355SRPW600410SRPW600076SRPW600141SRPW600163SRPW600213SRPW600094SRPW600206S
- Amount recalled
- 664 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.