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FDAMay 10, 2023device

CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

0064316972031200763000059545

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators — Recall Details · AllClear