Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; 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: 3852 units Lot/code info: GTIN 00763000001605, Lot Serial Numbers: CWP603713S, CWP601986S, CWP600810S, CWP602954S, CWP602169S, CWP602564S, CWP602486S, CWP601838S, CWP600696S, CWP602627S, CWP602315S, CWP602621S, CWP604004S, CWP603407S, CWP603894S, CWP604066S, CWP602233S, CWP603772S, CWP603201S, CWP603888S, CWP602797S, CWP603582S, CWP603254S, CWP603475S, CWP602907S, CWP603605S, CWP603606S, CWP602148S, CWP602999S, CWP601940S, CWP602860S, CWP600692S, CWP600693S, CWP601684S, CWP601750S, CWP602026S, CWP602250S, CWP602395S, CWP600661S, CWP600672S, CWP600673S, CWP601025S, CWP601261S, CWP601303S, CWP601404S, CWP601545S, CWP601730S, CWP601740S, CWP601753S, CWP601912S, CWP602158S, CWP602213S, CWP602504S, CWP602670S, CWP603190S, CWP603321S, CWP603588S, CWP601814S, CWP603269S, CWP600319S, CWP600528S, CWP600165S, CWP600198S, CWP600259S, CWP600347S, CWP600382S, CWP600924S, CWP601414S, CWP601449S, CWP601852S, CWP602821S, CWP602897S, CWP602949S, CWP602991S, CWP604050S, CWP601592S, CWP600897S, CWP602865S, CWP600265S, CWP600261S, CWP602153S, CWP600326S, CWP600355S, CWP600697S, CWP600738S, CWP602332S, CWP603593S, CWP600566S, CWP601527S, CWP601561S, CWP600205S, CWP601559S, CWP602115S, CWP600948S, CWP602089S, CWP602090S, CWP602259S, CWP600701S, CWP600954S, CWP601021S, CWP601092S, CWP601271S, CWP601606S, CWP601830S, CWP601886S, CWP601975S, CWP602092S, CWP602349S, CWP603000S, CWP603182S, CWP603241S, CWP603359S, CWP600131S, CWP600634S, CWP600863S, CWP600946S, CWP602578S, CWP603255S, CWP600285S, CWP601037S, CWP601530S, CWP6016

UPC codes

00763000001605

Source

Official record: FDA (Device enforcement) ↗

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