FDAFDA · Food and drugs·Recall number Z-1822-2023
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; 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 00763000178536, Lot Serial Numbers: RSG600215S, RSG600106S, RSG600196S, RSG600208S, RSG600223S, RSG600280S, RSG600125S, RSG600193S, RSG600006S, RSG600016S, RSG600123S, RSG600136S, RSG600573S, RSG600113S, RSG600249S, RSG600395S, RSG600579S, RSG600173S, RSG600111S, RSG600112S, RSG600116S, RSG600118S, RSG600130S, RSG600143S, RSG600175S, RSG600191S, RSG600205S, RSG600209S, RSG600272S, RSG600564S, RSG600167S, RSG600187S, RSG600077S, RSG600131S, RSG600145S, RSG600162S, RSG600245S, RSG600253S, RSG600512S, RSG600519S, RSG600037S, RSG600536S, RSG600544S, RSG600210S, RSG600643S, RSG600642S, RSG600122S, RSG600138S, RSG600174S, RSG600200S, RSG600225S, RSG600233S, RSG600585S, RSG600134S, RSG600168S, RSG600148S, RSG600132S, RSG600240S, RSG600055S, RSG600121S, RSG600179S, RSG600186S, RSG600158S, RSG600181S, RSG600219S, RSG600108S, RSG600164S, RSG600255S, RSG600511S, RSG600109S, RSG600110S, RSG600115S, RSG600117S, RSG600178S, RSG600250S, RSG600560S, RSG600083S, RSG600581S, RSG600639S, RSG600140S, RSG600232S, RSG600126S, RSG600141S, RSG600152S, RSG600166S, RSG600183S, RSG600204S, RSG600228S, RSG600242S, RSG600243S, RSG600246S, RSG600278S, RSG600114S, RSG600190S, RSG600201S, RSG600137S, RSG600157S, RSG600172S, RSG600171S, RSG600537S, RSG600185S, RSG600163S, RSG600546S, RSG600231S, RSG600144S, RSG600220S, RSG600107S, RSG600237S, RSG600554S, RSG600119S, RSG600520S, RSG600625S, RSG600627S; GTIN 00763000178543, Lot Serial Numbers: RSG600567S, RSG600684S, RSG600753S, RSG600654S, RSG600347S, RSG600349S, RSG600833S, RSG600842S, RSG600829S, RSG600700S, RSG600705S, RSG600730S, RSG600362S, RSG600868S, RSG600729S, RSG600803S, RSG600313S, RSG600584S, RSG600688S, RSG600827S, RSG600079S, RSG600306S, RSG600103S, RSG600105S, RSG600317S, RSG600474S, RSG600741S, RSG600379S, RSG600529S, RSG600656S, RSG600657S, RSG600674S, RSG600738S, RSG600330S, RSG600380S, RSG600063S, RSG600315S, RSG600316S, RSG600334S, RSG600335S, RSG600476S, RSG600572S, RSG600673S, RSG600332S, RSG600333S, RSG600619S, RSG600311S, RSG600444S, RSG600050S, RSG600070S, RSG600320S, RSG600652S, RSG600052S, RSG600327S, RSG600609S, RSG600582S, RSG600371S, RSG600319S, RSG600089S, RSG600477S, RSG600591S, RSG600039S, RSG600041S, RSG600053S, RSG600054S, RSG600057S, RSG600072S, RSG600324S, RSG600369S, RSG600383S, RSG600445S, RSG600455S, RSG600506S, RSG600571S, RSG600595S, RSG600599S, RSG600615S, RSG600630S, RSG600638S, RSG600739S, RSG600740S, RSG600743S, RSG600847S, RSG600851S, RSG600908S, RSG600909S, RSG600757S, RSG600760S, RSG600810S, RSG600814S, RSG600926S, RSG600927S, RSG600534S, RSG600568S, RSG600719S, RSG600761S, RSG600676S, RSG600481S, RSG600651S, RSG600325S, RSG600912S, RSG600742S, RSG600745S, RSG600746S, RSG600073S, RSG600087S, RSG600314S, RSG600322S, RSG600337S, RSG600363S, RSG600382S, RSG600569S, RSG600025S, RSG600368S, RSG600084S, RSG600007S, RSG600008S, RSG600009S, RSG600012S, RSG600013S, RSG600014S, RSG600023S, RSG600024S, RSG600026S, RSG600029S, RSG600042S, RSG600366S, RSG600377S, RSG600404S, RSG600458S, RSG600603S, RSG600680S, RSG600028S, RSG600708S, RSG600574S, RSG600398S, RSG600374S, RSG600040S, RSG600059S, RSG600074S, RSG600088S, RSG600098S, RSG600412S, RSG600018S, RSG600020S, RSG600033S, RSG600402S, RSG600060S, RSG600011S, RSG600022S, RSG600049S, RSG600367S, RSG600010S, RSG600058S, RSG600484S, RSG600043S, RSG600045S, RSG600397S, RSG600400S, RSG600661S, RSG600350S, RSG600351S, RSG600352S, RSG600354S, RSG600355S, RSG600357S, RSG600358S, RSG600359S, RSG600360S, RSG600361S, RSG600394S, RSG600414S, RSG600448S, RSG600451S, RSG600508S, RSG600522S, RSG600523S, RSG600524S, RSG600526S, RSG600543S, RSG600669S, RSG600655S, RSG600648S, RSG600852S, RSG600430S, RSG600431S, RSG600432S, RSG600469S, RSG600470S, RSG600471S, RSG600507S, RSG600527S, RSG600528S, RSG600530S, RSG600531S, RSG600541S, RSG600551S, RSG600415S, RSG600427S, RSG600428S, RSG600429S, RSG600439S, RSG600454S, RSG600461S, RSG600525S, RSG600550S, RSG600637S, RSG600722S, RSG600386S, RSG600387S, RSG600388S, RSG600389S, RSG600390S, RSG
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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