Reported Jun 28, 2023 · Ongoing
CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; 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 COBALT HF QUAD MRI IS4 DF4Model Number DTPB2QQImplantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178178
- Lot Serial numbers
2,714 of 2,714 codes
RTK605097SRTK600114SRTK600141SRTK600852SRTK600858SRTK601106SRTK601201SRTK602089SRTK602953SRTK603591SRTK604031SRTK600525SRTK602527SRTK606714SRTK608837SRTK608930SRTK610777SRTK600938SRTK600939SRTK600940SRTK601391SRTK601392SRTK601393SRTK601395SRTK604983SRTK604984SRTK604033SRTK606189SRTK606293SRTK606647SRTK606683SRTK606985SRTK606988SRTK607188SRTK607189SRTK607190SRTK607191SRTK607242SRTK610835SRTK603685SRTK605333SRTK601363SRTK602275SRTK602876SRTK603055SRTK600536SRTK603273SRTK603414SRTK603912SRTK604677SRTK602444SRTK602532SRTK602533SRTK602534SRTK603360SRTK603873SRTK603874SRTK603875SRTK604155SRTK604215S
- Amount recalled
- 15427 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.