FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: 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.
- Recall number
- Z-2854-2011
- 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.
- Status
- Terminated
- Initiated
- 2011-06-10
- Posted
- 2011-07-21
- Terminated
- 2011-07-27
- Reason
- 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
- 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
- 35 units
- Distribution
- Nationwide (USA) Distribution including the state of New York.
- Lot, serial or model codes
- Catalog #: VSP550 Lots: 0XK, 0YK, 09K.
- 510(k) numbers
- ["K092789"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28