Recall archive / FDA device enforcement

ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators — FDA record Z-1812-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
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.
Classification: Class I
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity: 6525 units
Agency-reported status: Ongoing
Source record identifier: Z-1812-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
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CWF604661S, CWF604663S, CWF604954S, CWF605004S, CWF605045S, CWF605047S, CWF6...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00643169837775, Lot Serial Numbers: CWF606066S, CWF601772S, CWF604835S, CWF604967S, CWF605332S, CWF601390S, CWF603522S, CWF602774S, CWF605900S, CWF600919S, CWF600938S, CWF601256S, CWF601551S, CWF601593S, CWF601753S, CWF601934S, CWF601936S, CWF602109S, CWF602581S, CWF602772S, CWF603413S, CWF603447S, CWF605891S, CWF602270S, CWF602324S, CWF602338S, CWF602553S, CWF602554S, CWF602674S, CWF602675S, CWF602677S, CWF602751S, CWF602752S, CWF602816S, CWF602823S, CWF602996S, CWF602998S, CWF603000S, CWF603013S, CWF603171S, CWF603174S, CWF603319S, CWF603361S, CWF603362S, CWF603363S, CWF603393S, CWF603406S, CWF603408S, CWF603718S, CWF603720S, CWF603721S, CWF603829S, CWF603830S, CWF603831S, CWF603832S, CWF603925S, CWF603931S, CWF603944S, CWF603996S, CWF603999S, CWF604002S, CWF604003S, CWF604004S, CWF604007S, CWF604008S, CWF604010S, CWF604598S, CWF604686S, CWF604814S, CWF604816S, CWF606151S, CWF606180S, CWF601291S, CWF601561S, CWF601672S, CWF601977S, CWF602155S, CWF606035S, CWF601562S, CWF601736S, 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CWF605004S, CWF605045S, CWF605047S, CWF6...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide - Worldwide Distribution

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 28, 2023
Recall initiation date: May 10, 2023
Center classification date: Jun 16, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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