Z-1069-2014Class II

VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, SterileRx Only

Name: Z-1069-2014 VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only***
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-12-12
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-12-12 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of VirtuoSaph Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting... on 2013-12-12. FDA classified it as Class II and gives the reason as "Sterility of medical devices intended for use in surgical procedures may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1069-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-12
Posted: 2014-02-21
Terminated: 2015-07-28
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Sterility of medical devices intended for use in surgical procedures may be compromised.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Terumo CVS notified afected end users by phone on December 12, 2013 and advised that they had become aware that the sterile packaging barrier was breached in specific lots of VirtuoSaph Plus Endoscopic Vessel Harvesting Systems. Customers were requested to return all unused affected product and verify that all users at their institution have been made aware of the risks associated with using the affected devices. For questions call 734-663-4145.
Quantity in commerce: 26 units
Distribution: USA Nationwide Distribution in the state of LA, NJ, and NY.
Product codes and lots: Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1069-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1069-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)