Getinge has recalled the Vasoview Hemopro 1 and 1.5 endoscopic vessel harvesting systems for silicone detachment, and is working with the FDA to evaluate reports of similar problems with its Vasoview Hemopro 2. [Image courtesy of Getinge]
Getinge issued an Urgent Medical Device Removal notice in September telling customers to stop using and return its Vasoview Hemopro 1.5 (VH-3500) and Vasoview Hemopro 1 (VH-3000-W, marketed outside of the U.S. only). The device manufacturer received at least 18 complaints, all but one involving serious injury.
“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,” the FDA said. “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.”
Of the 17 reports of serious injury due to silicone debris, the debris could not be removed from the patient in three cases.
The FDA said it is also working with the manufacturer to evaluate reports of silicone detachment with Vasoview Hemopro 2 (VH-4000 and VH-4001) systems.
With those devices unavailable for use, the FDA expects a shortage of electrosurgical cutting and coagulation devices and accessories (product code GEI) through the end of 2024.
The agency recommended health care providers consider alternatives from other manufacturers or suppliers, but acknowledged that the Vasoview Hemopro systems may be the only option available in certain circumstances, offering the following guidance:
“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.”
Getinge announced in March 2024 that it won FDA 510(k) clearance for the Vasoview Hemopro 3. At the time, the company said it planned to launch the next-generation system sometime in the third quarter, but the system is not yet listed at the company’s EVH product page.
