Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Check against the official notice below — it lists the full affected range.
Medtronic is recalling certain Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide. The recalled devices include Cobalt VR ICD models DVPB3D1 and DVPB3D4, and Cobalt DR ICD models DDPB3D1 and others. A total of 2,866 units have been identified, distributed globally.
These devices have the potential to deliver reduced shock energy at approximately 79% of programmed energy during high-voltage therapy. The recall affects specific serial numbers listed in the FDA record. The source document does not specify a remedy or corrective 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: 2866 units Lot/code info: a. Model Numbers: DVPB3D1: GTIN 00763000178499, Serial Numbers: RSE600212S, RSE600229S, RSE600406S, RSE600450S, RSE600505S, RSE600518S, RSE600519S, RSE600520S, RSE600538S, RSE600539S, RSE600621S, RSE600676S, RSE600681S, RSE600709S, RSE600715S, RSE600716S, RSE600717S, RSE600718S, RSE600725S, RSE600748S, RSE600756S, RSE600768S, RSE601500S, RSE601523S, RSE601579S, RSE601590S, RSE601603S, RSE601702S, RSE601705S, RSE601716S, RSE601718S, RSE601729S, RSE601746S, RSE601747S, RSE601768S, RSE601774S, RSE601780S, RSE601791S, RSE601802S, RSE601819S, RSE601828S, RSE601835S, RSE601841S, RSE601846S, RSE601857S, RSE601879S, RSE601885S, RSE601889S, RSE601890S, RSE601894S, RSE601899S, RSE601900S, RSE601906S, RSE601910S, RSE601914S, RSE601930S, RSE601935S, RSE601936S, RSE601937S, RSE601939S, RSE601940S, RSE601941S, RSE601945S, RSE601947S, RSE601952S, RSE601959S, RSE601965S, RSE602046S, RSE602047S, RSE602048S, RSE602049S, RSE602053S, RSE602060S, RSE602063S, RSE602064S, RSE602067S, RSE602081S, RSE602086S, RSE602087S, RSE602090S, RSE602092S, RSE602097S, RSE602111S, RSE602112S, RSE602123S, RSE602126S, RSE602139S, RSE602144S, RSE602145S, RSE602146S, RSE602147S, RSE602148S, RSE602149S, RSE602151S, RSE602154S, RSE602165S, RSE602166S, RSE602167S, RSE602169S, RSE602180S, RSE602181S, RSE602186S, RSE602189S, RSE602190S, RSE602191S, RSE602192S, RSE602196S, RSE602198S, RSE602200S, RSE602202S, RSE602203S, RSE602212S, RSE602214S, RSE602215S, RSE602240S, RSE602241S, RSE602244S, RSE602249S, RSE602250S, RSE60225
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.