VasoView HemoPro 2 Device for Coronary Bypass Surgeries Recalled After Injury Reports: FDA

An urgent medical device notification has been issued to physicians over problems with Getinge and Maquet Cardiovascular VasoView HemoPro 2 Endoscopic Vessel Harvesting (EVH) systems, which may have faulty heater wires and silicone attachments.

VasoView HemoPro 2 EVH systems are used during minimally invasive surgeries, such as coronary bypass graft surgery, to obtain blood vessels from within the patient’s body, which can then be used to create new bypasses and restore blood flow to the heart.

The device consists of a set of tools, including an endoscope, specialized instruments for vessel dissection and retrieval, and a heater wire designed to regulate temperature during the procedure.

The U.S. Food and Drug Administration (FDA) announced the Getinge and Maquet VasoView HemoPro 2 recall on January 15, warning healthcare professionals to review safety guidelines, as defects in the devices could result in serious health risks, including bleeding, burns, injuries, blood vessel blockages, infections and even death.

Getinge and Maquet first issued an Urgent Medical Device Correction letter for the VasoView HemoPro 2 EVH system on December 9, 2024, due to the potential risk of the heater wire bending or becoming detached, or the silicone peeling and detaching from the jaws of the harvesting tool during use.

The manufacturer has become aware of at least four injuries related to the heater wire, and three more linked to the silicone peeling or detaching.

As a result, the FDA has classified this action as a Class I recall, the most serious type, indicating that continued use of the product could result in serious injury or death.

The recall involves Getinge and Maquet Cardiovascular VasoView HemoPro 2 Endoscopic Vessel Harvesting Systems, both with a Vasoshield (VH-4001) and without (VH-4000). Affected Unique Device Identifiers (UDI) and models include: 00607567700406/VH-4000 and 00607567700451/VH-4001.

Healthcare providers were previously alerted to an older VasoView HemoPro EVH system recall through an Urgent Medical Device Field Correction letter on November 15, following 17 reports of serious injuries caused by faulty heater wires and silicone on the VasoView HemoPro 1 and 1.5 EVH systems. These are the same issues that are now affecting the VasoView HemoPro 2 EVH system.

The FDA’s original letter to health care providers recommends the following actions:

• Review the Instructions for Use and the FDA’s letter before using the affected device.
• Pay special attention to warnings about minimizing the amount of energy used.
• Inspect the device prior, during and after use for any signs of damage, including silicone detaching from the jaws, rough outer surfaces, sharp edges or unusual protrusions that may pose a hazard.
• Stop using the device if there are missing or damaged parts or any silicone peeling.
• Monitor patients for complications if it is suspected that fragments of the device may have been left inside of them, then locate and remove any components which may have fragmented inside the patient.

The manufacturer requests that customers complete and sign the Medical Device Removal Response Form attached to the letter and return it to Maquet Cardiovascular/Getinge by email at Hemopro-peeling-detachedsilicone2024.act@getinge.com or fax to 1-866-594-8101.

For more information, customers can contact Maquet Cardiovascular/Getinge customer support at 1-888-880-2874 or the FDA’s Division of Industry and Consumer Education.