Reported Jun 28, 2023 · Ongoing
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; 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 DVMD3D4 PRIMO MRIModel Number DVMD3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000001544
- Lot Serial Numbers
2,714 of 2,714 codes
CWL609971SCWL607669SCWL607665SCWL601100SCWL608311SCWL608330SCWL606893SCWL611845SCWL613316SCWL613041SCWL613322SCWL613037SCWL612708SCWL610673SCWL613504SCWL613431SCWL610444SCWL611258SCWL612781SCWL611134SCWL612934SCWL610677SCWL610760SCWL611725SCWL612705SCWL612392SCWL612791SCWL613155SCWL608262SCWL613137SCWL613177SCWL613296SCWL613214SCWL613134SCWL610869SCWL612023SCWL605532SCWL604332SCWL604336SCWL604346SCWL604350SCWL604352SCWL604353SCWL604357SCWL604361SCWL604363SCWL604365SCWL604367SCWL604368SCWL605564SCWL605583SCWL605779SCWL607583SCWL607825SCWL608913SCWL608914SCWL608966SCWL609174SCWL601407SCWL602224S
- Amount recalled
- 14270 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.