Reported Jun 28, 2023 · Ongoing
ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; 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 DDME3D4 MIRRO MRIModel Number DDME3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001582
- Lot Serial Numbers
2,714 of 2,714 codes
CWT605432SCWT600264SCWT607420SCWT607213SCWT607463SCWT607388SCWT607425SCWT607374SCWT607359SCWT601622SCWT603529SCWT605876SCWT605723SCWT604657SCWT604666SCWT605105SCWT605034SCWT608381SCWT608194SCWT606083SCWT604306SCWT606483SCWT607258SCWT606731SCWT605978SCWT607015SCWT606443SCWT607932SCWT608011SCWT607139SCWT606486SCWT605678SCWT607017SCWT607943SCWT608012SCWT606735SCWT606736SCWT606738SCWT606739SCWT606741SCWT606742SCWT606743SCWT606744SCWT606745SCWT606746SCWT606747SCWT606748SCWT606749SCWT606750SCWT603376SCWT607308SCWT602883SCWT603530SCWT604069SCWT604509SCWT604647SCWT604878SCWT605689SCWT605944SCWT606036S
- Amount recalled
- 8219 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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