# FDA recall Z-1367-2021

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2021-03-02.

## Product

Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.

## Reason for recall

There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

## Distribution

US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.

## Key facts

- **Recall number:** Z-1367-2021
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-02
- **Report date:** 2021-04-14
- **Termination date:** 2021-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elkton, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1367-2021

## Citation

> AI Analytics. FDA recall Z-1367-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1367-2021. Source: US FDA. Licensed CC0.

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