FDA Device Recall Z-1796-2023

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Mounds View, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators

Lot / serial / GTIN: GTIN 00643169720435, Lot Serial Number: BWH224619H, BWH224621H, BWH224620H, BWH224623H

Quantity: 4 units

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.

Recall record

Recall number: Z-1796-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide - Worldwide Distribution
Recall initiated: 2023-05-10
Classified by FDA Center: 2023-06-16
FDA published: 2023-06-28
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Firm location: Mounds View, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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