FDAFDA · Food and drugs·Recall number Z-1800-2023
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
Published June 28, 2023 · Recall initiated: May 10, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- US Nationwide - Worldwide Distribution
- Lot
- GTIN 00643169720442, Lot Serial Numbers: BWL206052H, BWL205879H, BWL206062H, BWL206106H, BWL206057H, BWL206066H, BWL206087H, BWL205882H, BWL206049H, BWL206050H, BWL206053H, BWL206055H, BWL206059H, BWL206069H, BWL206073H, BWL206074H, BWL206078H, BWL206079H, BWL206081H, BWL206082H, BWL206083H, BWL206084H, BWL206101H, BWL206104H, BWL206110H, BWL206112H, BWL206116H, BWL206118H, BWL206120H, BWL206122H, BWL206123H, BWL206126H, BWL206127H, BWL206068H, BWL206071H, BWL206092H, BWL206093H, BWL206094H, BWL206109H, BWL206117H, BWL206119H, BWL206097H, BWL205878H, BWL206098H, BWL206063H, BWL206114H, BWL206108H, BWL206048H, BWL206064H, BWL206058H, BWL206086H, BWL206099H, BWL206076H, BWL206103H, BWL206107H, BWL206124H, BWL206125H, BWL206105H, BWL206051H, BWL206054H; GTIN 00643169720459, Lot Serial Numbers: BWL606762S, BWL606799S, BWL609508S, BWL606741S, BWL607597S, BWL607510S, BWL607234S, BWL606748S, BWL607162S, BWL607513S, BWL607947S, BWL606791S, BWL607876S, BWL606995S, BWL607071S, BWL606857S, BWL606752S, BWL607088S, BWL606806S, BWL606900S, BWL606908S, BWL606738S, BWL606758S, BWL606759S, BWL607084S, BWL607199S, BWL607220S, BWL607277S, BWL607512S, BWL607519S, BWL607558S, BWL607571S, BWL607805S, BWL607806S, BWL609503S, BWL609505S, BWL609506S, BWL606452S, BWL606742S, BWL606743S, BWL606751S, BWL606757S, BWL606766S, BWL606767S, BWL606805S, BWL606840S, BWL606899S, BWL606942S, BWL607001S, BWL607013S, BWL607074S, BWL607215S, BWL607423S, BWL607542S, BWL607590S, BWL607593S, BWL607594S, BWL607613S, BWL607716S, BWL607910S, BWL608035S, BWL606781S, BWL606807S, BWL606837S, BWL606838S, BWL607609S, BWL606948S, BWL607556S, BWL607569S, BWL607581S, BWL607587S, BWL607721S, BWL607032S, BWL607034S, BWL607560S, BWL607610S, BWL607657S, BWL607902S, BWL609738S, BWL606872S, BWL607028S, BWL607030S, BWL607508S, BWL607509S, BWL607540S, BWL607635S, BWL607638S, BWL607705S, BWL607911S, BWL607958S, BWL607280S, BWL607666S, BWL607302S, BWL607961S, BWL607035S, BWL607036S, BWL607956S, BWL606746S, BWL606754S, BWL606765S, BWL607075S, BWL607073S, BWL607192S, BWL607194S, BWL607196S, BWL607536S, BWL607568S, BWL607573S, BWL607608S, BWL607630S, BWL607631S, BWL607884S, BWL607894S, BWL607900S, BWL607901S, BWL606749S, BWL606750S, BWL607043S, BWL607044S, BWL607505S, BWL607506S, BWL607595S, BWL607596S, BWL607727S, BWL607730S, BWL607010S, BWL607011S, BWL607223S, BWL607945S, BWL607269S, BWL608004S, BWL607255S, BWL606725S, BWL606726S, BWL606727S, BWL606776S, BWL606798S, BWL607959S, BWL606941S, BWL607038S, BWL607306S, BWL607903S, BWL607086S, BWL607555S, BWL607557S, BWL608138S, BWL607507S, BWL607012S, BWL607298S, BWL606718S, BWL606734S, BWL607219S, BWL606735S, BWL608113S, BWL607469S, BWL607224S, BWL606760S, BWL606761S, BWL606847S, BWL606851S, BWL606853S, BWL606876S, BWL607543S, BWL608031S, BWL607530S, BWL607531S, BWL606901S, BWL607305S, BWL607714S, BWL607718S, BWL606846S, BWL607588S, BWL606994S, BWL606848S, BWL606756S, BWL607029S, BWL607193S, BWL607951S, BWL607272S, BWL606717S, BWL609633S, BWL607500S, BWL607037S, BWL607867S, BWL607885S, BWL606728S, BWL609911S, BWL606768S, BWL606769S, BWL606789S, BWL606790S, BWL607316S, BWL607222S, BWL607575S, BWL607578S, BWL607580S, BWL607582S, BWL607586S, BWL607591S, BWL607592S, BWL607599S, BWL607601S, BWL607603S, BWL607606S, BWL607607S, BWL607618S, BWL607619S, BWL607249S, BWL607517S, BWL607662S, BWL608028S, BWL607221S, BWL607371S, BWL609557S, BWL607047S, BWL607503S, BWL607518S, BWL607798S, BWL608732S, BWL608754S, BWL609502S, BWL609658S, BWL606733S, BWL607007S, BWL606835S, BWL606810S, BWL607541S, BWL606935S, BWL606936S, BWL606987S, BWL606988S, BWL606989S, BWL606990S, BWL606993S, BWL607585S, BWL607616S, BWL607624S, BWL607649S, BWL607688S, BWL607690S, BWL608194S, BWL608251S, BWL608321S, BWL608322S, BWL608323S, BWL608324S, BWL608326S, BWL608389S, BWL608398S, BWL608400S, BWL608976S, BWL608984S, BWL608990S, BWL609019S, BWL609179S, BWL609183S, BWL607745S, BWL607754S, BWL608116S, BWL608140S, BWL608143S, BWL606755S, BWL606930S, BWL607002S, BWL607022S, BWL607366S, BWL
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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