# FDA recall Z-2215-2026

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2026-04-21.

## Product

Medtronic GUNDRY Retrograde Cannula  Manual-Inflate  Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter

## Reason for recall

Certain lots of product have the potential for a sterile barrier breach.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.

## Key facts

- **Recall number:** Z-2215-2026
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-21
- **Report date:** 2026-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn Park, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2215-2026

## Citation

> MORVS. FDA recall Z-2215-2026. Retrieved 2026-10-15 from https://api.morvs.ai/recall/Z-2215-2026. Source: US FDA. Licensed CC0.

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