# FDA recall Z-0585-2018

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

## Product

Implantable Cardioverter Defibrillators (ICDs), Evera MRI.  Labeled as the following:    a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1);    b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4);    c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4);    d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1);      EXPANSION:    e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4)     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-0585-2018
- **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-0585-2018

## Citation

> AI Analytics. FDA recall Z-0585-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0585-2018. Source: US FDA. Licensed CC0.

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