VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System — Class II medical device recall Z-1069-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-03-05, distributed nationwide. Sterility of medical devices intended for use in surgical procedures may be compromised.
| Recall number | Z-1069-2014 |
|---|---|
| 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 | 2013-12-12 |
| Classified | 2014-02-21 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2015-07-28 |
| Distributed | Nationwide (US) |
| Quantity | 26 units |
| Reason classes | sterility |
| Lot numbers | 21K, 31K, 32K, 33K, 34K, 35K |
| Model numbers | VSP550 |
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.
Reason for recall
Sterility of medical devices intended for use in surgical procedures may be compromised.
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-1069-2014. 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.