Class II — Terumo Cardiovascular Systems Corporation
| Recalling firm | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
|---|---|
| Registered facility | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. |
| 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. |
| Quantity | 12 |
| Distribution | US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA. |
| Initiated | 2021-03-02 |
| Classified | 2021-04-06 |
| Terminated | 2021-11-05 |
| Recall number | Z-1367-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo Cardiovascular Systems Corporation (Z-1367-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87504/
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