November 15, 2024

The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. 

On September 20, 2024, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to not use VasoView HemoPro 1.5 (VH-3500) and VasoView HemoPro 1 (VH-3000-W, which is marketed only outside of the United States) devices. There is a risk that silicone may detach from the jaws of the harvesting tool during use, resulting in the device becoming non-functional and/or silicone debris entering the patient. Detachment of silicone into the patient can lead to an EVH procedural delay and/or conversion of the EVH procedure to a more invasive open vessel harvest procedure. 

Getinge/Maquet received 18 complaints for HemoPro 1.5 devices between April 1, 2024, and July 31, 2024, related to silicone detaching from the jaws of the harvesting tool during use. There were 17 reports of serious injury due to silicone debris being introduced to the patients including three instances where this debris was unable to be removed.

The FDA is aware that the removal of VasoView HemoPro 1.5 from use may interrupt the supply of EVH devices. The FDA has updated the medical device shortage list to include EVH devices. See "FDA Actions" below. 

In addition, the FDA is working with the manufacturer to evaluate reports of silicone detachment with VasoView HemoPro 2 (VH-4000 and VH-4001) devices. 

The FDA is issuing this letter to help ensure that health care providers and facilities are aware of the manufacturer’s recall notice for VasoView HemoPro 1.5 devices, the ongoing evaluation of potential safety concerns with VasoView HemoPro 2 devices, and supply concern for EVH devices, and the FDA’s recommendations on alternative options. 

Recommendations 

• Review the recall notice from Getinge/Maquet for removal and return of all unused VasoView HemoPro 1.5 (VH-3500) devices due to risk of silicone detachment. 
• Be aware that the FDA has received reports of silicone detachment with VasoView HemoPro 2 devices and continues to work with the manufacturer to evaluate the issue. 
• Consider other manufacturers or suppliers of EVH devices to determine if alternatives are available and appropriate. Use alternative devices if possible. 
  • Look for FDA-cleared EVH devices by searching the 510(k) database for Product Code GEI or “endoscopic vessel harvesting”
• The FDA recognizes that, despite the risks presented by the VasoView HemoPro devices, alternative options are limited and the VasoView HemoPro 1.5 and 2 may be the only options available to you in certain circumstances. If you deem it necessary to continue  using VasoView HemoPro 1.5 and 2 devices until an alternative is available, consider the following related to silicone detachment to mitigate the risks:
  • Inspect the device prior to use for any signs of damage including silicone peeling away from the jaws.
    • Check the outer surface of the device for rough surfaces, sharp edges, or unusual protrusions that may be a hazard.
  • Monitor the device during use for silicone peeling away from the jaws
  • Inspect the device after use for missing or damaged parts.  
  • If, at any time of use, the user notices missing or damaged parts or peeling of silicone, device use should be terminated, and any fragmented components should be located and removed from the patient.
  • Monitor patients for complications if you suspect fragment(s) of the device may have been retained. Future complications could include delayed onset of pain, infection, and/or localized allergic/adverse reaction. 
• Be aware of other recalls related to VasoView HemoPro 1.5 and 2 devices. Read any Urgent Medical Device Recall notices from Getinge/Maquet and follow the recommendations. Information on additional recalls can be found at Medical Device Recalls
• Report any adverse events or supply issues with VasoView HemoPro 1.5 and 2 devices to the FDA. See "Reporting Problems to the FDA" below.

Background

The VasoView HemoPro Endoscopic Vessel Harvesting Systems are designed for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass. 

FDA Actions

The FDA has identified the recall for VasoView HemoPro 1.5 devices as a Class I recall, the most serious type of recall. The FDA will continue to monitor issues with VasoView HemoPro 1.5 and 2 devices, and the actions being taken by the manufacturer to address safety concerns.

On November 15, 2024, the FDA added EVH devices (product code GEI) to the medical device shortage list. Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the devices the FDA has determined to be in shortage. The FDA also reviews each notification received under section 506J of the FD&C Act and uses this information, along with any additional details about the supply and demand of a device, to determine whether a device is in shortage.

The FDA will continue to work with health care providers and facilities to assist with challenges related to available options for EVH devices. The FDA is working with Getinge/Maquet and other manufacturers to identify potential strategies to help support availability of these critical devices.

The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

You can find the UDI provided by Getinge/Maquet for VasoView HemoPro devices by checking the table below.

* model only marketed outside of the United States

Reporting Problems to the FDA

If you are experiencing supply issues with EVH devices or other devices, contact the FDA about a medical device supply chain issue. Reporting supply issues informs the FDA of how it may be able to help address device supply availability.

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with EVH devices. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).