Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; 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: 2767 units Lot/code info: GTIN 00643169720718, Lot Serial Numbers: RPJ204877H, RPJ205009H, RPJ205996H, RPJ206294H, RPJ205851H, RPJ206501H, RPJ205969H, RPJ205051H, RPJ206429H, RPJ205893H, RPJ205344H, RPJ206237H, RPJ206208H, RPJ206032H, RPJ206082H, RPJ206104H, RPJ205080H, RPJ205234H, RPJ206059H, RPJ205438H, RPJ206376H, RPJ205287H, RPJ205509H, RPJ206342H, RPJ205891H, RPJ204872H, RPJ204899H, RPJ204933H, RPJ204973H, RPJ205142H, RPJ205777H, RPJ205989H, RPJ206295H, RPJ205059H, RPJ205148H, RPJ205732H, RPJ205873H, RPJ206504H, RPJ205500H, RPJ206357H, RPJ204876H, RPJ206359H, RPJ206369H, RPJ205623H, RPJ206218H, RPJ205743H, RPJ206172H, RPJ204917H, RPJ205981H, RPJ205041H, RPJ205073H, RPJ205235H, RPJ205246H, RPJ205279H, RPJ206045H, RPJ205880H, RPJ206050H, RPJ206207H, RPJ205049H, RPJ204888H, RPJ205038H, RPJ205039H, RPJ205047H, RPJ205053H, RPJ205054H, RPJ205333H, RPJ205334H, RPJ205349H, RPJ205420H, RPJ205471H, RPJ205510H, RPJ205593H, RPJ205717H, RPJ205727H, RPJ205982H, RPJ206074H, RPJ206186H, RPJ206234H, RPJ204891H, RPJ205317H, RPJ205918H, RPJ205410H, RPJ206238H, RPJ206500H, RPJ204998H, RPJ205089H, RPJ205560H, RPJ205770H, RPJ206389H, RPJ205871H, RPJ205872H, RPJ205876H, RPJ205957H, RPJ206198H, RPJ206199H, RPJ206418H, RPJ206499H, RPJ204956H, RPJ205488H, RPJ205784H, RPJ205964H, RPJ206004H, RPJ206308H, RPJ206480H, RPJ205339H, RPJ205425H, RPJ205427H, RPJ205428H, RPJ205468H, RPJ206159H, RPJ206178H, RPJ206368H, RPJ206485H, RPJ206486H, RPJ206355H, RPJ206483H, RPJ205003H, RPJ205006H, RPJ205716H, RPJ205845H, RPJ206012H, RPJ2062

UPC codes

00643169720718, 00763000059675

Source

Official record: FDA (Device enforcement) ↗

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