Reported Jun 28, 2023 · Ongoing
CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; 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 DTMB2D4 AMPLIA MRI OUS DF4Model Number DTMB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720725
- Lot Serial Numbers
2,714 of 2,714 codes
RPK603310SRPK606030SRPK607323SRPK606692SRPK605552SRPK604274SRPK607156SRPK607510SRPK606721SRPK606379SRPK606753SRPK603895SRPK607997SRPK608001SRPK608115SRPK602608SRPK602842SRPK602915SRPK603155SRPK603438SRPK603475SRPK604209SRPK604230SRPK604885SRPK605001SRPK605994SRPK606046SRPK606664SRPK607134SRPK608665SRPK604002SRPK604373SRPK605499SRPK605680SRPK603963SRPK607543SRPK607544SRPK607943SRPK608088SRPK608203SRPK607149SRPK607416SRPK607418SRPK607615SRPK608212SRPK608297SRPK608298SRPK609062SRPK604646SRPK605555SRPK605685SRPK606797SRPK604171SRPK605262SRPK605291SRPK605292SRPK606475SRPK607086SRPK603372SRPK603375S
- Amount recalled
- 8575 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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