Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; 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: 8602 units Lot/code info: GTIN 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS206225H, RPS208216H, RPS206084H, RPS203804H, RPS208198H, RPS208245H, RPS205937H, RPS205565H, RPS206114H, RPS206723H, RPS206730H, RPS206733H, RPS206734H, RPS206754H, RPS207303H, RPS207318H, RPS207338H, RPS207399H, RPS207703H, RPS207711H, RPS207722H, RPS208049H, RPS208505H, RPS208646H, RPS208679H, RPS205303H, RPS205918H, RPS203315H, RPS204385H, RPS205650H, RPS202760H, RPS203013H, RPS203034H, RPS203256H, RPS203610H, RPS205372H, RPS206383H, RPS206771H, RPS207603H, RPS207933H, RPS208110H, RPS208492H, RPS204009H, RPS202981H, RPS207563H, RPS208546H, RPS202245H, RPS203960H, RPS204342H, RPS204357H, RPS205958H, RPS207822H, RPS207840H, RPS207922H, RPS207923H, RPS207984H, RPS208255H, RPS208529H, RPS208575H, RPS208590H, RPS208615H, RPS203563H, RPS206128H, RPS206413H, RPS206762H, RPS207904H, RPS208608H, RPS202171H, RPS202841H, RPS202860H, RPS203565H, RPS204198H, RPS202792H, RPS202793H, RPS206515H, RPS202224H, RPS203192H, RPS203545H, RPS203910H, RPS204035H, RPS204166H, RPS204197H, RPS204394H, RPS204492H, RPS205560H, RPS206777H, RPS207146H, RPS207520H, RPS208166H, RPS204464H, RPS204776H, RPS207117H, RPS204003H, RPS205323H, RPS206063H, RPS208464H, RPS206252H, RPS202211H, RPS202602H, RPS202612H, RPS205006H, RPS205638H, RPS205639H, RPS205710H, RPS205998H, RPS207105H, RPS207368H, RPS207409H, RPS202030H, RPS202067H, RPS202507H, RPS206211H, RPS206605H, RPS207137H, RPS208591H, RPS2020

UPC codes

00643169837669

Source

Official record: FDA (Device enforcement) ↗

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