# FDA recall Z-1807-2023

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class I · device recall initiated 2023-05-10.

## Product

ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1;  Implantable Cardioverter Defibrillators

## 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.

## Distribution

US Nationwide - Worldwide Distribution

## Key facts

- **Recall number:** Z-1807-2023
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-10
- **Report date:** 2023-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1807-2023

## Citation

> AI Analytics. FDA recall Z-1807-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1807-2023. Source: US FDA. Licensed CC0.

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