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 | Sterility of medical devices intended for use in surgical procedures may be compromised. |
| Product | VirtuoSaph® Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. |
| Quantity | 26 units |
| Distribution | USA Nationwide Distribution in the state of LA, NJ, and NY. |
| Initiated | 2013-12-12 |
| Classified | 2014-02-21 |
| Terminated | 2015-07-28 |
| Recall number | Z-1069-2014 |
| 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-1069-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67193/
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