Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD COBALT VR MRI DF4, Model Number DVPB3D4; 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: 7048 units Lot/code info: GTIN 00763000178512, Lot Serial Numbers: RSF600012S, RSF600254S, RSF600591S, RSF600655S, RSF600822S, RSF601247S, RSF602653S, RSF603908S, RSF601102S, RSF607914S, RSF605967S, RSF600633S, RSF600649S, RSF600867S, RSF600868S, RSF600869S, RSF600872S, RSF600873S, RSF600874S, RSF600875S, RSF600876S, RSF600878S, RSF600880S, RSF600883S, RSF602930S, RSF602991S, RSF602998S, RSF603002S, RSF603003S, RSF603013S, RSF603018S, RSF603019S, RSF603022S, RSF603026S, RSF603027S, RSF603030S, RSF603032S, RSF603033S, RSF603034S, RSF603035S, RSF603036S, RSF603736S, RSF603737S, RSF603741S, RSF603742S, RSF603744S, RSF603746S, RSF603747S, RSF603749S, RSF603754S, RSF603755S, RSF603756S, RSF603758S, RSF603759S, RSF603762S, RSF603763S, RSF603764S, RSF603799S, RSF603802S, RSF603804S, RSF603806S, RSF603810S, RSF603813S, RSF603818S, RSF603821S, RSF603824S, RSF602665S, RSF602703S, RSF603249S, RSF603648S, RSF603939S, RSF607644S, RSF601171S, RSF601174S, RSF602584S, RSF602743S, RSF600887S, RSF602678S, RSF608130S, RSF600767S, RSF608097S, RSF604855S, RSF606263S, RSF601206S, RSF601486S, RSF601567S, RSF601571S, RSF600924S, RSF601224S, RSF601226S, RSF602817S, RSF603405S, RSF603521S, RSF603678S, RSF602595S, RSF604129S, RSF600687S, RSF600210S, RSF602849S, RSF607243S, RSF607244S, RSF607291S, RSF604110S, RSF604146S, RSF605150S, RSF607995S, RSF600352S, RSF601546S, RSF607225S, RSF606605S, RSF600269S, RSF600940S, RSF601190S, RSF603550S, RSF604130S, RSF608014S, RSF600303S, RSF602434S, RSF602435S, RSF602449S, RSF602461S, RSF6024

UPC codes

00763000178512

Source

Official record: FDA (Device enforcement) ↗

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