# FDA recall Z-0588-2018

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class I · device recall initiated 2017-12-19.

## Product

Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following:   a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1);    b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4);      EXPANSION:    c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1);    d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4)     Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

## Reason for recall

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

## Distribution

US Nationwide Distribution.

## Key facts

- **Recall number:** Z-0588-2018
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-19
- **Report date:** 2018-02-28
- **Termination date:** 2021-08-27

- **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-0588-2018

## Citation

> AI Analytics. FDA recall Z-0588-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0588-2018. Source: US FDA. Licensed CC0.

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