Consist of a distal connection mechanism — Class II medical device recall Z-1367-2021
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2021-04-14, distributed nationwide. There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanis
| Recall number | Z-1367-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2021-03-02 |
| Classified | 2021-04-06 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2021-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 12 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00699753450950 |
| Serial numbers | T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412 |
| Model numbers | T401163 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1367-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.