Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
Check against the official notice below — it lists the full affected range.
Medtronic is recalling certain Cobalt XT implantable cardioverter defibrillators (ICDs) and related cardiac devices distributed worldwide due to a potential defect that could reduce shock energy to approximately 79% of programmed levels during high-voltage therapy. The affected models include the Cobalt XT VR ICD (Model Numbers DVPA2D1, DVPA2D4) and Cobalt XT DR ICD (Model Number DDPA2), with 6,884 units affected across multiple serial numbers.
The recall document does not specify what action affected consumers should take in response to this recall.
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: 6884 units Lot/code info: a. Model Numbers: DVPA2D1: GTIN 00763000178451, Serial Numbers: RSC600237S, RSC600256S, RSC600277S, RSC600327S, RSC600419S, RSC601038S, RSC601061S, RSC601065S, RSC601084S, RSC601126S, RSC601134S, RSC601138S, RSC601158S, RSC601159S, RSC601175S, RSC601193S, RSC601209S, RSC601210S, RSC601213S, RSC601214S, RSC601217S, RSC601226S, RSC601242S, RSC601244S, RSC601249S, RSC601313S, RSC601314S, RSC601315S, RSC601317S, RSC601323S, RSC601330S, RSC601332S, RSC601337S, RSC601341S, RSC601342S, RSC601346S, RSC601349S, RSC601354S, RSC601358S, RSC601370S, RSC601372S, RSC601377S, RSC601379S, RSC601397S, RSC601402S, RSC601411S, RSC601420S, RSC601422S, RSC601438S, RSC601441S, RSC601446S, RSC601453S, RSC601467S, RSC601473S, RSC601476S, RSC601486S, RSC601493S, RSC601494S, RSC601500S, RSC601506S, RSC601510S, RSC601511S, RSC601516S, RSC601520S, RSC601525S, RSC601526S, RSC601532S, RSC601539S, RSC601542S, RSC601581S, RSC601622S, RSC601627S, RSC601628S, RSC601631S, RSC601635S, RSC601636S, RSC601644S, RSC601650S, RSC601651S, RSC601659S, RSC601674S, RSC601676S, RSC601678S, RSC601680S, RSC601681S, RSC601683S, RSC601690S, RSC601693S, RSC601694S, RSC601696S, RSC601697S, RSC601698S, RSC601699S, RSC601702S, RSC601704S, RSC601705S, RSC601707S, RSC601708S, RSC601712S, RSC601714S, RSC601721S, RSC601722S, RSC601726S, RSC601733S, RSC601756S; GTIN 00763000178475, Serial Numbers: RSC600021S, RSC600025S, RSC600029S, RSC600031S, RSC600037S, RSC600053S, RSC600056S, RSC600059S, RSC600062S, RSC600063S, RSC600077S, RSC6002
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.