# FDA recall Z-0726-2026

> **Medtronic, Inc.** · Class II · device recall initiated 2025-10-29.

## Product

Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

## Reason for recall

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0726-2026
- **Recalling firm:** Medtronic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-29
- **Report date:** 2025-12-10

- **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-0726-2026

## Citation

> AI Analytics. FDA recall Z-0726-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0726-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*