FDAFDA · Alimentos y medicamentos·N.º oficial Z-1489-2022
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Publicado el 17 de agosto de 2022 · Inicio del retiro: 22 de junio de 2022
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distribuidor
- Worldwide Distribution
- Lote
- a. Model Numbers: DVPC3D1: GTIN 00763000178543, Serial Numbers: RSG600007S, RSG600008S, RSG600009S, RSG600010S, RSG600011S, RSG600012S, RSG600013S, RSG600014S, RSG600017S, RSG600018S, RSG600020S, RSG600022S, RSG600023S, RSG600024S, RSG600025S, RSG600026S, RSG600027S, RSG600028S, RSG600029S, RSG600030S, RSG600031S, RSG600033S, RSG600036S, RSG600039S, RSG600040S, RSG600041S, RSG600042S, RSG600043S, RSG600045S, RSG600047S, RSG600049S, RSG600050S, RSG600052S, RSG600053S, RSG600054S, RSG600056S, RSG600057S, RSG600058S, RSG600059S, RSG600060S, RSG600063S, RSG600065S, RSG600066S, RSG600068S, RSG600070S, RSG600072S, RSG600073S, RSG600074S, RSG600075S, RSG600079S, RSG600084S, RSG600087S, RSG600088S, RSG600089S, RSG600098S, RSG600101S, RSG600103S, RSG600105S, RSG600305S, RSG600306S, RSG600310S, RSG600311S, RSG600313S, RSG600314S, RSG600315S, RSG600316S, RSG600317S, RSG600319S, RSG600320S, RSG600322S, RSG600324S, RSG600325S, RSG600327S, RSG600330S, RSG600332S, RSG600333S, RSG600334S, RSG600335S, RSG600337S, RSG600347S, RSG600348S, RSG600349S, RSG600350S, RSG600351S, RSG600352S, RSG600354S, RSG600355S, RSG600356S, RSG600357S, RSG600358S, RSG600359S, RSG600360S, RSG600361S, RSG600362S, RSG600363S, RSG600364S, RSG600365S, RSG600366S, RSG600367S, RSG600368S, RSG600370S, RSG600371S, RSG600374S, RSG600375S, RSG600376S, RSG600377S, RSG600379S, RSG600380S, RSG600382S, RSG600383S, RSG600384S, RSG600385S, RSG600386S, RSG600387S, RSG600388S, RSG600389S, RSG600390S, RSG600391S, RSG600392S, RSG600393S, RSG600394S, RSG600396S, RSG600397S, RSG600398S, RSG600399S, RSG600400S, RSG600401S, RSG600402S, RSG600403S, RSG600404S, RSG600405S, RSG600407S, RSG600408S, RSG600409S, RSG600410S, RSG600412S, RSG600413S, RSG600414S, RSG600415S, RSG600417S, RSG600418S, RSG600419S, RSG600420S, RSG600421S, RSG600422S, RSG600423S, RSG600424S, RSG600425S, RSG600426S, RSG600427S, RSG600428S, RSG600429S, RSG600430S, RSG600431S, RSG600432S, RSG600433S, RSG600434S, RSG600435S, RSG600436S, RSG600437S, RSG600438S, RSG600439S, RSG600440S, RSG600441S, RSG600442S, RSG600444S, RSG600445S, RSG600446S, RSG600447S, RSG600448S, RSG600449S, RSG600450S, RSG600451S, RSG600452S, RSG600453S, RSG600454S, RSG600456S, RSG600457S, RSG600458S, RSG600459S, RSG600460S, RSG600461S, RSG600462S, RSG600463S, RSG600464S, RSG600465S, RSG600466S, RSG600467S, RSG600469S, RSG600470S, RSG600471S, RSG600472S, RSG600474S, RSG600476S, RSG600478S, RSG600479S, RSG600480S, RSG600482S, RSG600485S; DVPC3D4: GTIN 00763000178550, Serial Numbers: RSH600816S, RSH600826S, RSH600910S, RSH600917S GTIN 00763000178567, Serial Numbers: RSH600006S, RSH600008S, RSH600009S, RSH600011S, RSH600012S, RSH600015S, RSH600016S, RSH600017S, RSH600018S, RSH600019S, RSH600020S, RSH600021S, RSH600023S, RSH600024S, RSH600025S, RSH600027S, RSH600028S, RSH600029S, RSH600030S, RSH600032S, RSH600033S, RSH600034S, RSH600035S, RSH600185S, RSH600190S, RSH600200S, RSH600202S, RSH600206S, RSH600209S, RSH600210S, RSH600212S, RSH600213S, RSH600214S, RSH600217S, RSH600226S, RSH600227S, RSH600233S, RSH600237S, RSH600242S, RSH600243S, RSH600244S, RSH600245S, RSH600246S, RSH600247S, RSH600248S, RSH600252S, RSH600254S, RSH600255S, RSH600256S, RSH600269S, RSH600270S, RSH600271S, RSH600272S, RSH600273S, RSH600279S, RSH600283S, RSH600324S, RSH600354S, RSH600355S, RSH600357S, RSH600359S, RSH600362S, RSH600363S, RSH600368S, RSH600371S, RSH600373S, RSH600374S, RSH600376S, RSH600377S, RSH600378S, RSH600379S, RSH600380S, RSH600381S, RSH600382S, RSH600383S, RSH600384S, RSH600385S, RSH600388S, RSH600389S, RSH600390S, RSH600395S, RSH600396S, RSH600397S, RSH600398S, RSH600399S, RSH600400S, RSH600401S, RSH600402S, RSH600403S, RSH600404S, RSH600405S, RSH600406S, RSH600408S, RSH600409S, RSH600410S, RSH600411S, RSH600412S, RSH600413S, RSH600414S, RSH600415S, RSH600418S, RSH600419S, RSH600420S, RSH600421S, RSH600422S, RSH600423S, RSH600424S, RSH600425S, RSH600426S, RSH600428S, RSH600429S, RSH600430S, RSH600431S, RSH600432S, RSH600434S, RSH600435S, RSH600436S, RSH6
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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