Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; 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: 3570 units Lot/code info: GTIN 00643169837621, Lot Serial Numbers: RPO604357S, RPO603344S, RPO603999S, RPO603613S, RPO602588S, RPO603485S, RPO603586S, RPO603863S, RPO601733S, RPO603715S, RPO601235S, RPO601389S, RPO601698S, RPO601771S, RPO602006S, RPO602325S, RPO602359S, RPO602456S, RPO602547S, RPO602630S, RPO602667S, RPO602723S, RPO602912S, RPO602956S, RPO603277S, RPO603281S, RPO603474S, RPO603611S, RPO604037S, RPO604118S, RPO604253S, RPO604259S, RPO604282S, RPO604326S, RPO604369S, RPO604405S, RPO604406S, RPO603440S, RPO603702S, RPO603703S, RPO604049S, RPO604050S, RPO604051S, RPO604073S, RPO603075S, RPO601669S, RPO601697S, RPO601763S, RPO602062S, RPO602101S, RPO602494S, RPO602703S, RPO602722S, RPO603071S, RPO603199S, RPO603211S, RPO603337S, RPO603351S, RPO603374S, RPO603645S, RPO603832S, RPO603958S, RPO604249S, RPO604448S, RPO601161S, RPO601166S, RPO601351S, RPO601519S, RPO601648S, RPO601993S, RPO602166S, RPO603371S, RPO603558S, RPO603585S, RPO603608S, RPO603644S, RPO603657S, RPO604149S, RPO604234S, RPO604396S, RPO604415S, RPO601299S, RPO603042S, RPO604021S, RPO601893S, RPO602016S, RPO603962S, RPO604147S, RPO604306S, RPO604347S, RPO601471S, RPO601485S, RPO601591S, RPO601680S, RPO601738S, RPO601973S, RPO602107S, RPO602217S, RPO602241S, RPO602411S, RPO602736S, RPO602831S, RPO602842S, RPO603193S, RPO603306S, RPO603466S, RPO603818S, RPO603960S, RPO603981S, RPO604136S, RPO604183S, RPO604207S, RPO604231S, RPO604404S, RPO604421S, RPO601711S, RPO602582S, RPO601419S, RPO603463S, RPO603992S, RPO604102S, RPO6040

UPC codes

00643169837621

Source

Official record: FDA (Device enforcement) ↗

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