Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; 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: 14270 units Lot/code info: GTIN 00763000001544, Lot Serial Numbers: CWL609971S, CWL607669S, CWL607665S, CWL601100S, CWL608311S, CWL608330S, CWL606893S, CWL611845S, CWL613316S, CWL613041S, CWL613322S, CWL613037S, CWL612708S, CWL610673S, CWL613504S, CWL613431S, CWL610444S, CWL611258S, CWL612781S, CWL611134S, CWL612934S, CWL610677S, CWL610760S, CWL611725S, CWL612705S, CWL612392S, CWL612791S, CWL613155S, CWL608262S, CWL613137S, CWL613177S, CWL613296S, CWL613214S, CWL613134S, CWL610869S, CWL612023S, CWL605532S, CWL604332S, CWL604336S, CWL604346S, CWL604350S, CWL604352S, CWL604353S, CWL604357S, CWL604361S, CWL604363S, CWL604365S, CWL604367S, CWL604368S, CWL605564S, CWL605583S, CWL605779S, CWL607583S, CWL607825S, CWL608913S, CWL608914S, CWL608966S, CWL609174S, CWL601407S, CWL602224S, CWL604372S, CWL604374S, CWL607414S, CWL607688S, CWL609146S, CWL609294S, CWL610670S, CWL604082S, CWL604249S, CWL604273S, CWL604611S, CWL605101S, CWL605102S, CWL605103S, CWL605105S, CWL605106S, CWL605233S, CWL605235S, CWL605632S, CWL605645S, CWL605652S, CWL606263S, CWL606411S, CWL606795S, CWL607038S, CWL607089S, CWL607337S, CWL607340S, CWL607415S, CWL607803S, CWL608025S, CWL608038S, CWL608141S, CWL608274S, CWL609467S, CWL609469S, CWL609499S, CWL609898S, CWL609902S, CWL609905S, CWL609912S, CWL609921S, CWL610114S, CWL610121S, CWL610633S, CWL611480S, CWL611482S, CWL611483S, CWL611484S, CWL611485S, CWL611487S, CWL611488S, CWL611493S, CWL612304S, CWL612305S, CWL612306S, CWL612307S, CWL612308S, CWL612309S, CWL613023S, CWL613025S, CWL6130

UPC codes

00763000001544

Source

Official record: FDA (Device enforcement) ↗

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