Reported Jun 28, 2023 · Ongoing
ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; 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-VR DVMD3D1 PRIMO MRIModel Number DVMD3D1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001520
- Lot Serial Numbers
2,714 of 2,714 codes
CWK604305SCWK601554SCWK601693SCWK601762SCWK603310SCWK600674SCWK605298SCWK605119SCWK605216SCWK605052SCWK605244SCWK605024SCWK605176SCWK605108SCWK605326SCWK605015SCWK605215SCWK605100SCWK605123SCWK604958SCWK605229SCWK605502SCWK604624SCWK604625SCWK604396SCWK605478SCWK604413SCWK604933SCWK605391SCWK601948SCWK601949SCWK601950SCWK601953SCWK601961SCWK601965SCWK601966SCWK601970SCWK601971SCWK601972SCWK601974SCWK601976SCWK602568SCWK602617SCWK602627SCWK602632SCWK602691SCWK602827SCWK602843SCWK602870SCWK601348SCWK603369SCWK604247SCWK604852SCWK603773SCWK601726SCWK601802SCWK602031SCWK602325SCWK602330SCWK602332S
- Amount recalled
- 5215 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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