Recall Z-0227-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Terumo Cardiovascular Systems Corporation
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding
| Date | Aug 31, 2018 |
| Status | Terminated |
| Reason | The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Correction notification letters dated August 29, 2018 were distributed to customers. The letter identified the affected product, problem and actions to be take. Customers were instructed to: Review this Medical Device Correction Notification and the Recommended Actions. Assure that all users receive notice of this issue. Confirm receipt of this correction notification by emailing or faxing the attached Customer Response Form to the email address or fax number indicated on the form. Ensure that users are notified of the revised IFU provided with this notification (Re |
| Quantity | 135 |
| Distribution | Worldwide - US Nationwide in the states of FL, IL, NY, OH, TX. The products were distributed to the following foreign country: Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140008 | VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM Terumo Cardiovascular Systems Corporation, Oct 31, 2014 |