FDA warns providers on Getinge devices tied to 17 serious injuries

Dive Brief:

The Food and Drug Administration alerted healthcare providers Friday about the safety and supply of Getinge/Maquet vessel harvesting devices.
The letter to providers describes issues with Getinge/Maquet VasoView Hemopro Endoscopic Vessel Harvesting (EVH) Systems. Getinge recalled the devices in September after receiving 18 complaints about Hemopro 1.5 devices in four months, including reports of 17 serious injuries.
The FDA letter addresses the injury reports and warns the removal of Hemopro 1.5 may interrupt the supply of EVH devices. The devices are now on the FDA’s device shortage list.

Dive Insight:

Physicians use Hemopro 1, which is only marketed outside the U.S., and Hemopro 1.5 to create a new path for blood flow in the arteries in patients undergoing endoscopic surgery. The devices allow access for vessel harvesting during minimally invasive procedures.

Getinge and its subsidiary Maquet Cardiovascular recalled the Hemopro devices because of a risk that silicone may detach from the jaws of the harvesting tool during use. The detachment can stop the devices from working and cause silicone debris to enter the patient. Potential consequences include procedural delays and the switch from EVH to a more invasive vessel harvest procedure.

The FDA alerted healthcare professionals to 17 reports of serious injuries related to silicone debris being introduced to the patients. Physicians were unable to remove the debris in three instances.

Getinge asked customers to remove all affected devices from use. The FDA said the product removal may interrupt the supply of EVH devices. The agency added EVH devices to its list of shortages, estimating supply disruptions may continue through the fourth quarter of 2024.

Because of the disruption, the FDA has asked healthcare providers to consider other manufacturers or suppliers of EVH devices. The agency said alternative options are limited, though, and Hemopro devices may be the only options available. In that situation, healthcare professionals can keep using the affected Hemopro devices until an alternative is available.

Physicians should inspect the device before use for signs of damage such as silicone peeling away from the jaws, the FDA said, and check the product again during and after use. Patients who may have debris in them should be monitored for complications, the agency added.

The alert is the latest in a series of regulatory actions related to Getinge. The company paused the promotion of certain balloon pumps and cardiopulmonary bypass devices in the U.S. in May after the FDA told healthcare providers to stop using the devices.