Addressing Safety and Accessibility Issues Surrounding VasoView HemoPro Endoscopic Vessel Harvesting Systems – Communication to Health Care Professionals

November 15, 2024

The U.S. Food and Drug Administration (FDA) is warning healthcare professionals and facilities regarding safety issues linked to Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, coupled with concerns about the availability of these devices.

On September 20, 2024, Getinge/Maquet disseminated an Urgent Medical Device Removal notice, advising users against the application of VasoView HemoPro 1.5 (VH-3500) and VasoView HemoPro 1 (VH-3000-W, which is exclusively marketed outside the U.S.). There exists a risk of silicone separating from the jaws of the harvesting instrument during operation, leading to the device’s malfunction and/or the introduction of silicone fragments into the patient. Such detachment can result in delays during the EVH procedure or a shift to a more invasive open vessel harvesting method.

Between April 1, 2024, and July 31, 2024, Getinge/Maquet garnered 18 complaints regarding the HemoPro 1.5 devices, citing silicone separation from the harvesting tool’s jaws during procedures. There were 17 instances of severe injury attributed to silicone fragments being introduced into patients, which included three occasions where the debris could not be retrieved.

The FDA acknowledges that the pullback of VasoView HemoPro 1.5 could impact the supply of EVH instruments. As such, the FDA has revised its medical device shortage list to incorporate EVH devices. For further details, refer to “FDA Actions” mentioned below.

Moreover, the FDA is collaborating with the manufacturer to assess reports pertaining to silicone detachment associated with VasoView HemoPro 2 (VH-4000 and VH-4001) devices.

This correspondence is issued by the FDA to ensure that healthcare facilities and personnel are informed of the manufacturer’s recall notice for VasoView HemoPro 1.5 devices, the ongoing scrutiny regarding potential safety issues concerning VasoView HemoPro 2 devices, and the supply issues affecting EVH devices, in addition to the FDA’s guidance on alternative solutions.

Recommendations

• Review the Getinge/Maquet recall notice for the removal and return of all unused VasoView HemoPro 1.5 (VH-3500) devices due to the risk of silicone separation.
• Stay vigilant, as the FDA has received reports concerning silicone separation in VasoView HemoPro 2 devices and is actively collaborating with the manufacturer regarding this concern.
• Explore options from other manufacturers or suppliers of EVH devices to identify feasible alternatives. Use alternative devices where possible.
  • Search for FDA-cleared EVH devices in the 510(k) database using Product Code GEI or the term “endoscopic vessel harvesting.”
• While recognizing the risks posed by VasoView HemoPro devices, alternative options can be scarce. If use of VasoView HemoPro 1.5 and 2 devices is deemed necessary until alternatives become available, consider the following precautions regarding silicone detachment:
  • Inspect devices prior to utilization for any signs of damage, including silicone peeling from the jaws.
    • Examine the device’s outer surface for sharp edges, rough patches, or anomalous protrusions that could pose hazards.
  • Monitor the device during use for signs of silicone peeling from the jaws.
  • Check the device post-use for any missing or damaged components.
  • Should any signs of damage or silicone detachment be observed during use, discontinue the device’s application and ensure that any fragmented pieces are located and extracted from the patient.
  • Watch for potential complications if fragments of the device might have been retained, with indications such as delayed pain, infection, or localized allergic reactions.
• Stay informed on other recalls concerning VasoView HemoPro 1.5 and 2 devices. Pay attention to any Urgent Medical Device Recall notices from Getinge/Maquet and adhere to the advised instructions. Additional recall information can be found at Medical Device Recalls.
• Report any adverse events or supply problems related to 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 facilitate minimally invasive surgeries by allowing access for vessel collection, chiefly indicated for patients undergoing endoscopic procedures for arterial bypass.

FDA Actions

The FDA has categorized the recall of VasoView HemoPro 1.5 devices as a Class I recall, which ranks as the most critical type of recall. The FDA will persist in monitoring issues related to VasoView HemoPro 1.5 and 2 devices, including scrutinizing the resolutions undertaken by the manufacturer to tackle safety issues.

As of November 15, 2024, the FDA has added EVH devices (product code GEI) to the medical device shortage list. Under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is mandated to maintain a current, publicly accessible list of devices identified as being in shortage. The FDA reviews each notification received under this section, leveraging that information alongside further details about the device’s supply and demand to ascertain any shortages.

The FDA remains dedicated to aiding healthcare providers and facilities in addressing challenges related to the availability of EVH devices. The agency is working in collaboration with Getinge/Maquet and other manufacturers to explore potential strategies that may bolster the availability of these essential devices.

The FDA will continue to provide updates to healthcare professionals and the public as new or additional information becomes available.

Unique Device Identifier (UDI)

The FDA implemented a unique device identification system to effectively recognize medical devices sold in the U.S., tracing them from production through distribution to patient application.

For the UDI associated with Getinge/Maquet’s VasoView HemoPro devices, please refer to the table below.

* model only marketed outside of the United States

Reporting Problems to the FDA

If you face supply challenges with EVH devices or other medical devices, inform the FDA about a medical device supply chain concern. Reporting supply challenges helps the FDA identify how it may assist in addressing device availability.

The FDA encourages healthcare professionals to report any adverse events or suspected events associated with EVH devices. Timely reporting of adverse events can enhance the FDA’s understanding of the risks related to medical devices.

Contact Information

If you have inquiries about this notification, reach out to the Division of Industry and Consumer Education (DICE).