Reported Jun 28, 2023 · Ongoing
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; 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 XT HF MRI IS1 DF1Model Number DTPA2D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178147
- Lot Serial numbers
2,559 of 2,559 codes
RTH601483SRTH602021SRTH602022SRTH602302SRTH602303SRTH602305SRTH602306SRTH605169SRTH602089SRTH603993SRTH601526SRTH600467SRTH600514SRTH600533SRTH600607SRTH600608SRTH601387SRTH601543SRTH601544SRTH601545SRTH602017SRTH605116SRTH600520SRTH602108SRTH604790SRTH602149SRTH605081SRTH605082SRTH604360SRTH604780SRTH604943SRTH604734SRTH600153SRTH601390SRTH601395SRTH601849SRTH601868SRTH602192SRTH602619SRTH600554SRTH602035SRTH602694SRTH600170SRTH602206SRTH601611SRTH602091SRTH602195SRTH603628SRTH600220SRTH600223SRTH600228SRTH600288SRTH601447SRTH601448SRTH601449SRTH601450SRTH602055SRTH602056SRTH602057SRTH602058S
- Lot Serial Numbers
152 of 152 codes
RTH600974SRTH601847SRTH604279SRTH604723SRTH604947SRTH603847SRTH601928SRTH605331SRTH605120SRTH603234SRTH605362SRTH603799SRTH604680SRTH603976SRTH603183SRTH605111SRTH605293SRTH605354SRTH602743SRTH603964SRTH604813SRTH604754SRTH602314SRTH601930SRTH603999SRTH603815SRTH600036SRTH604758SRTH601468SRTH603245SRTH600083SRTH601285SRTH602334SRTH600328SRTH601015SRTH601191SRTH601359SRTH602322SRTH601172SRTH601869SRTH603235SRTH601013SRTH601073SRTH601074SRTH602124SRTH602323SRTH602331SRTH601068SRTH601189SRTH601472SRTH601489SRTH601604SRTH601887SRTH602286SRTH602337SRTH602462SRTH603196SRTH603773SRTH603774SRTH603951S
- Amount recalled
- 4151 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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