Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Check against the official notice below — it lists the full affected range.
Medtronic is recalling certain Crome implantable cardioverter defibrillator (ICD) models due to a potential defect that could reduce the shock energy delivered during high-voltage therapy to approximately 79% of the programmed energy level. The affected devices are the Crome VR ICD (Model Numbers DVPC3D1, DVPC3D4) and Crome DR ICD (Model Numbers DDPC3D1, DDPC3), with 1,657 units distributed worldwide. Specific serial numbers are identified in the recall notice.
This defect could impact the device's ability to deliver the full intended electrical therapy when needed. The recall record does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Worldwide Distribution Quantity: 1657 units Lot/code info: 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, RSG60039
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.