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Terminated

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.

FDA Recall Z-2854-2011 · Posted 2011-07-21

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeGCJ
Date Initiated2011-06-10
Date Terminated2011-07-27
Product Quantity35 units

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

Nationwide (USA) Distribution including the state of New York.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092789VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEMTerumo Cardiovascular Systems Corp. · 2010-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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