This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type of recall.

Affected Product 

• Product Names: VasoView HemoPro Endoscopic Vessel Harvesting System 
• Unique Device Identifier (UDI)/Model: 
  • 00607567700413/VH-3000-W (HemoPro 1, only marketed outside of the U.S.)
  • 00601551101250/VH-3500 (HemoPro 1.5) 
• Lot/Serial Numbers: See full list of affected devices   

What to Do

• Do not use affected VasoView HemoPro 1 and 1.5 Endoscopic Vessel Harvesting Systems 

On September 20, 2024, Getinge sent all affected customers an Urgent Medical Device Removal letter recommending the following actions: 

• Examine inventory immediately to determine if you have affected VasoView HemoPro EVH Systems.
• Remove all affected devices from use.
• Contact Maquet Cardiovascular/Getinge Customer Service at 1-888-880-2874 to request a return authorization number (RMA) and shipping instructions for unused/unexpired products. 
• Return unused/unexpired affected product to Maquet Cardiovascular/Getinge. 
• Complete and sign the Medical Device Removal Response Form attached to the letter, whether affected product is identified or not. 
• Return the completed form to Maquet Cardiovascular/Getinge by email: Hemopro-peelinq-detached­silicone2024.act@getinge.com or fax: 1-866-594-8101.
• Forward this information to all current and potential device users within your hospital/facility.
• Distributors should forward to any customers who may have received this product.

Reason for Recall   

Getinge and its subsidiary Maquet Cardiovascular is recalling VasoView HemoPro 1 (VH-3000-W) and 1.5 (VH-3500) Endoscopic Vessel Harvesting Systems due to the risk that silicone may detach from the harvesting tool during use, causing silicone debris to enter the patient. This can render the device non-functional, requiring replacement.

The use of affected product may cause serious adverse health consequences, including injury or blockage (embolism or occlusion) of blood vessels, infection, and death.

There have been 17 reported injuries. There have been no reports of death. 

Device Use 

VasoView HemoPro 1 and 1.5 Endoscopic Vessel Harvesting (EVH) Systems are indicated for use in minimally invasive surgery, allowing access for vessel harvesting. The system is used for patients undergoing endoscopic surgery to create a new path for blood flow in the arteries (arterial bypass).

Contact Information

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.

Full List of Affected Devices

Click to expand:

Additional FDA Resources (listed in order of most to least recent):  

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. 

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.