# FDA recall Z-1489-2022

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class I · device recall initiated 2022-06-22.

## Product

Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4

## Reason for recall

There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-1489-2022
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-22
- **Report date:** 2022-08-17

- **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-1489-2022

## Citation

> AI Analytics. FDA recall Z-1489-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1489-2022. Source: US FDA. Licensed CC0.

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