Z-2854-2011

VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System...

Name: Z-2854-2011 VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2011-06-10
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2011-06-10 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System Indicated for use in minimally invasive surgery... on 2011-06-10. The reason FDA records is "Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cases in a limited...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2854-2011
Status: Terminated
Initiated: 2011-06-10
Posted: 2011-07-21
Terminated: 2011-07-27
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: VirtuoSaph Plus Endoscopic Vessel Harvesting System , REF VSP550, Sterile, Terumo Cardiovascular System Indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or vessel harvesting along the saphenous vein for coronary artery bypass grafting and peripheral artery bypass grafting.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Terumo Cardiovascular Systems received four (4) complaints from a single customer about tunnel breathing/inadequate insufflation with the VirtuoSaph Plus Endoscopic Vessel Harvesting System during cases in a limited production launch situation. Teumo's investigation identified issues with the devices's capability to maintain pressure within the tunnel.
Root cause tag: design
FDA root cause: Device Design
Action: Terumo Cardiovascular Systems contacted the one customer to this device on June 10, 2010 by telephone. There was one consignee. The firm contacted this one consignee by phone on 6/10/2010. There were 2 contacts at this one consignee. The recalling firm contacted both of the contacts on 6/10/2010. The consignee was asked to dispose of remaking inventory of devices. The consignee said had disposed of the product. For information on this recall call (734) 741-6173
Quantity in commerce: 35 units
Distribution: Nationwide (USA) Distribution including the state of New York.
Product codes and lots: Catalog #: VSP550 Lots: 0XK, 0YK, 09K.

Product code GCJ

K092789Class IIVirtuosaph Plus Endoscopic Vessel Harvesting SystemTerumo Cardiovascular Systems Corp. / cleared 2010-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)