Reported Jun 28, 2023 · Ongoing
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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?
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1Model Number DDMC3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837737
- Lot Serial Numbers
2,714 of 2,714 codes
CWC602314SCWC602130SCWC601890SCWC607466SCWC602236SCWC602359SCWC608108SCWC607103SCWC601544SCWC601546SCWC605273SCWC602965SCWC604941SCWC605039SCWC601687SCWC601688SCWC602560SCWC602845SCWC603176SCWC603372SCWC603584SCWC603596SCWC603780SCWC603826SCWC603862SCWC604054SCWC604145SCWC604909SCWC605061SCWC605800SCWC607271SCWC607272SCWC607475SCWC608775SCWC608917SCWC608956SCWC608480SCWC608488SCWC603831SCWC604086SCWC604166SCWC604240SCWC604391SCWC604670SCWC604681SCWC604684SCWC604846SCWC604847SCWC605090SCWC605290SCWC605410SCWC605411SCWC605588SCWC605600SCWC605863SCWC605864SCWC605867SCWC605876SCWC605988SCWC605989S
- Amount recalled
- 10,903 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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