# FDA recall Z-0583-2018

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

## Product

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI.  Labeled as the following:    a. Compia MRI CRT-D DF1 (Product No. DTMC1D1);    b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ )    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-0583-2018
- **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-0583-2018

## Citation

> AI Analytics. FDA recall Z-0583-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0583-2018. Source: US FDA. Licensed CC0.

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