Reported Mar 5, 2014 · Terminated

VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The…

Terumo Cardiovascular Systems Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Terumo Cardiovascular Systems Corporation · 125 Blue Ball Rd · Elkton, MD · 21921-5315

Is this the product you have?

  • VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System
  • Part numberVSP550, Sterile***Rx Only***
  • Product UsageThe 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
Lot codes and dates
  • Lot numbers
    • 21K
    • 31K
    • 32K
    • 33K
    • 34K
    • 35K
Amount recalled
26 units

Where it was sold

Why it was recalled

Sterility of medical devices intended for use in surgical procedures may be compromised.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 28, 2015 · Data as of Sep 19, 5:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.