Reported Jun 28, 2023 · Ongoing
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; 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 DDMC3D4 EVERA MRI S IS-1/DF4 GLOBModel Number DDMC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720527
- Lot Serial Numbers
2,325 of 2,325 codes
PHZ203294HPHZ204099HPHZ202880HPHZ202731HPHZ203576HPHZ203873HPHZ202558HPHZ202949HPHZ203163HPHZ204430HPHZ203645HPHZ204171HPHZ204583HPHZ204585HPHZ204589HPHZ204600HPHZ204629HPHZ204676HPHZ204879HPHZ204932HPHZ204991HPHZ205067HPHZ205076HPHZ205168HPHZ205219HPHZ205254HPHZ205303HPHZ204750HPHZ202687HPHZ203913HPHZ203379HPHZ203419HPHZ203421HPHZ203422HPHZ203423HPHZ203425HPHZ203426HPHZ203427HPHZ203435HPHZ203798HPHZ203805HPHZ203808HPHZ203809HPHZ203811HPHZ203816HPHZ203819HPHZ203820HPHZ203822HPHZ203828HPHZ203829HPHZ203830HPHZ203831HPHZ204440HPHZ204442HPHZ204444HPHZ204445HPHZ204446HPHZ204447HPHZ204448HPHZ204449H
- Lot Serial Numbers
386 of 386 codes
PHZ613460SPHZ613462SPHZ613480SPHZ613482SPHZ613486SPHZ613643SPHZ613952SPHZ614046SPHZ614047SPHZ614483SPHZ614508SPHZ614800SPHZ615726SPHZ615727SPHZ615733SPHZ615768SPHZ615776SPHZ618593SPHZ618613SPHZ621169SPHZ620386SPHZ620392SPHZ620394SPHZ621168SPHZ621216SPHZ621191SPHZ613867SPHZ614796SPHZ614750SPHZ615203SPHZ618597SPHZ618567SPHZ618571SPHZ618576SPHZ618581SPHZ618590SPHZ618594SPHZ618592SPHZ618261SPHZ618570SPHZ618580SPHZ618589SPHZ618595SPHZ618267SPHZ618565SPHZ618569SPHZ618574SPHZ618578SPHZ618566SPHZ618268SPHZ615016SPHZ618587SPHZ614497SPHZ614503SPHZ613388SPHZ613876SPHZ614496SPHZ616971SPHZ613475SPHZ613967S
- Amount recalled
- 37,547 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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