Recall Announcement: Getinge and Maquet Cardiovascular Withdraw VasoView HemoPro 1 and 1.5 Endoscopic Vessel Harvesting Systems

This recall pertains to the removal of specific devices from their points of sale or use. The FDA categorizes this as a Class I recall, which represents the most severe level of recall.

Products Involved 

• 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: For a complete list of affected devices, visit here  

Recommended Actions

• Immediately cease the use of the affected VasoView HemoPro 1 and 1.5 Endoscopic Vessel Harvesting Systems 

On September 20, 2024, Getinge issued an Urgent Medical Device Removal letter advising the following steps: 

• Inspect your inventory to identify any affected VasoView HemoPro EVH Systems.
• Remove all affected products from usage.
• Reach out to Maquet Cardiovascular/Getinge Customer Service at 1-888-880-2874 for a return authorization number (RMA) and shipping directions for any unused/unexpired products. 
• Return unaffected/unexpired products to Maquet Cardiovascular/Getinge.
• Fill out and sign the Medical Device Removal Response Form provided with the letter, regardless of whether affected products are found.
• Email or fax the completed form back to Maquet Cardiovascular/Getinge at: Hemopro-peelinq-detached­silicone2024.act@getinge.com or fax: 1-866-594-8101.
• Disseminate this information to all current and potential device users in your facility.
• Distributors are to inform any customers who might have received these products.

Reason Behind the Recall  

Getinge, along with its subsidiary Maquet Cardiovascular, is executing this recall for the VasoView HemoPro 1 (VH-3000-W) and 1.5 (VH-3500) systems due to the possibility of silicone detaching from the harvesting tool while in use, potentially causing silicone debris to enter a patient. This situation can lead to device failure, necessitating its replacement.

Using the affected products may result in severe health risks, including blockage or injury to blood vessels, infections, and even death.

There have been 17 reported injuries, but no fatalities have been recorded. 

Device Application 

The VasoView HemoPro 1 and 1.5 Endoscopic Vessel Harvesting (EVH) Systems are intended for use in minimally invasive surgeries that facilitate vessel harvesting. This system assists patients who are experiencing endoscopic surgery aimed at creating new blood flow routes in arteries (arterial bypass).

Contact Details

U.S. customers needing information regarding this recall should contact their Maquet Cardiovascular/Getinge representative or call the Customer Support line at 1-888-880-2874.

Complete Inventory of Affected Devices

Click to expand:

Further Resources from the FDA (in order of recency): 

Unique Device Identifier (UDI) 

The unique device identifier (UDI) is designed to trace individual medical devices sold in the U.S. throughout their lifecycle from manufacturing to patient usage. This system facilitates accurate reporting and analysis of adverse events, enabling quicker identification and resolution of device-related issues. 

How to Report an Issue? 

Healthcare professionals and consumers can report any adverse reactions or quality issues encountered with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.