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Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems Due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use
Getinge and its subsidiary Maquet Cardiovascular are recalling VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the possibility of two failure modes experienced during use: a bent or detached heater wire and silicone peeling or detaching from the jaws of the harvesting tool.
The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves updating use instructions and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. If you continue to use it without following the updated instructions, this device may cause patient harms such as delayed onset of pain, infection, localized allergic/adverse reaction, and/or readmission to a medical facility for additional medical and/or surgical intervention to treat complications and/or attempt to retrieve retained material. This recall involves providing safety information to reduce potential for device related serious injury or death.
Questions?
Customers in the U.S. with questions about this recall should contact their Maquet Cardiovascular/Getinge representative or call Maquet Cardiovascular/Getinge Customer Support at 1-888-880-2874.
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