# FDA recall Z-1131-2022

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2022-04-20.

## Product

Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.

## Reason for recall

Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia, Netherlands, Poland, Russian Federation, Singapore, Switzerland.

## Key facts

- **Recall number:** Z-1131-2022
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-20
- **Report date:** 2022-06-01

- **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-1131-2022

## Citation

> AI Analytics. FDA recall Z-1131-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1131-2022. Source: US FDA. Licensed CC0.

---

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