Reported Jun 28, 2023 · Ongoing
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; 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 DVBB2D4 EVERA XT DF4 INTLModel Number DVBB2D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169218024
- Lot Serial Numbers
BWJ607141SBWJ607132SBWJ607040SBWJ607055SBWJ607056SBWJ607025SGTIN 00643169969575
- Lot Serial Numbers
150 of 150 codes
BWJ607007SBWJ607008SBWJ607010SBWJ607011SBWJ607012SBWJ607015SBWJ607020SBWJ607022SBWJ607024SBWJ607029SBWJ607034SBWJ607035SBWJ607037SBWJ607077SBWJ607347SBWJ607043SBWJ607091SBWJ607094SBWJ607095SBWJ607101SBWJ607342SBWJ607343SBWJ607344SBWJ606951SBWJ606991SBWJ606994SBWJ607005SBWJ607060SBWJ607090SBWJ607096SBWJ607097SBWJ607098SBWJ607120SBWJ607121SBWJ607127SBWJ607145SBWJ607146SBWJ607147SBWJ607149SBWJ607156SBWJ607158SBWJ607159SBWJ607160SBWJ607162SBWJ607092SBWJ607093SBWJ607003SBWJ607288SBWJ607280SBWJ607282SBWJ607286SBWJ607287SBWJ606996SBWJ606998SBWJ607016SBWJ607019SBWJ607057SBWJ607061SBWJ607062SBWJ607063S
- Lot Serial Numbers
288 of 288 codes
BWJ607465SBWJ607467SBWJ607468SBWJ607580SBWJ607395SBWJ607338SBWJ607339SBWJ607340SBWJ607341SBWJ607352SBWJ607353SBWJ607354SBWJ607355SBWJ607356SBWJ607357SBWJ607358SBWJ607359SBWJ607360SBWJ607361SBWJ607438SBWJ607377SBWJ607378SBWJ607381SBWJ607382SBWJ607383SBWJ607385SBWJ607386SBWJ607387SBWJ607389SBWJ607390SBWJ607413SBWJ607416SBWJ607418SBWJ607420SBWJ607511SBWJ607517SBWJ607521SBWJ607522SBWJ607743SBWJ607769SBWJ607772SBWJ607774SBWJ607776SBWJ607786SBWJ607376SBWJ607375SBWJ607380SBWJ607516SBWJ607541SBWJ607562SBWJ607612SBWJ607641SBWJ607749SBWJ607755SBWJ607770SBWJ607781SBWJ607722SBWJ607747SBWJ607497SBWJ607498S
- Lot Serial numbers
BWJ607792SBWJ607798SBWJ607795SBWJ607796SBWJ607797S
- Amount recalled
- 447 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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