Class II — Terumo Medical Corporation
| Recalling firm | TERUMO MEDICAL CORP. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve. |
| Product | PINNACLE® Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM® Sheath PINNACLE® TIF TIP" Introducer Sheath PINNACLE® R/O II Radiopaque Marker Introducer Sheath |
| Quantity | 1,370,995 eaches have been distributed to the field |
| Distribution | Nationwide Distribution |
| Initiated | 2016-03-16 |
| Classified | 2016-09-06 |
| Terminated | 2017-01-27 |
| Recall number | Z-2738-2016 |
| 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 Medical Corporation (Z-2738-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73833/
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