medical Class I Updated 2023-06-28

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; I

Recalled Product

CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 00643169968585, Lot Serial Numbers: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, BLC229010H
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