Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide - Worldwide Distribution Quantity: 2904 units Lot/code info: GTIN 00643169217966, Lot Serial Numbers: BLI613233S, BLI613324S, BLI613699S, BLI614038S, BLI614165S, BLI613293S, BLI613712S, BLI613772S, BLI614301S, BLI613871S, BLI614140S, BLI614826S, BLI612567S, BLI614031S, BLI613259S, BLI613417S, BLI614737S, BLI614194S, BLI614210S, BLI614604S, BLI613371S, BLI612853S, BLI612859S, BLI613234S, BLI613304S, BLI613305S, BLI613994S, BLI614312S, BLI614469S, BLI612711S, BLI612774S, BLI612954S, BLI613449S, BLI613588S, BLI613591S, BLI614002S, BLI614013S, BLI614290S, BLI614537S, BLI614600S, BLI612805S, BLI613296S, BLI614202S, BLI614460S, BLI613765S, BLI613867S, BLI614307S, BLI614462S, BLI614482S, BLI614593S, BLI612754S, BLI612627S, BLI612707S, BLI612922S, BLI613008S, BLI613255S, BLI613312S, BLI613592S, BLI613665S, BLI613874S, BLI614300S, BLI614304S, BLI614478S, BLI614550S, BLI612769S, BLI613229S, BLI613373S, BLI614302S, BLI614836S, BLI613865S, BLI612946S, BLI613750S, BLI614184S, BLI614577S, BLI613754S, BLI613758S, BLI612866S, BLI612961S, BLI614599S, BLI613275S, BLI613418S, BLI613649S, BLI613879S, BLI614325S, BLI612962S, BLI613272S, BLI614595S, BLI613243S, BLI613284S, BLI614472S, BLI612753S, BLI613334S, BLI613664S, BLI612828S, BLI614463S, BLI614487S, BLI614772S, BLI614781S, BLI612721S, BLI612752S, BLI613693S, BLI613790S, BLI612950S, BLI613294S, BLI613331S, BLI613332S, BLI614173S, BLI614535S, BLI614831S, BLI612781S, BLI612956S, BLI613231S, BLI612717S, BLI612902S, BLI614784S, BLI613992S, BLI612937S, BLI614227S, BLI612867S, BLI614167S, BLI613452S, BLI6140

UPC codes

00643169217966, 00643169720282, 00643169980099

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.