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Recall Observatory FDA recall evidence

Device product

ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators

Z-1792-2023

May 10, 2023

Class I

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 92328
Status
Ongoing
Classification
Class I
Quantity
12 units
Official record key
device-enforcement:Z-1792-2023

Official wording

Reason: 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.

Code information: GTIN 00643169720763, Lot Serial Numbers: BWT600023S, BWT600013S, BWT600014S, BWT600025S, BWT600029S, BWT600030S, BWT600032S, BWT600033S, BWT600034S, BWT600024S,; GTIN 00763000052706, Lot Serial Numbers: BWT600040S, BWT600038S

Distribution pattern: US Nationwide - Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.