# FDA recall Z-2201-2024

> **Medtronic Inc.** · Class II · device recall initiated 2024-04-16.

## Product

MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator

## Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2201-2024
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-16
- **Report date:** 2024-07-03

- **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-2201-2024

## Citation

> AI Analytics. FDA recall Z-2201-2024. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2201-2024. Source: US FDA. Licensed CC0.

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