FDA designates Class 1 recalls for EVH system, infusion pump

Editor's Note

The US Food and Drug Administration (FDA) has designated recent recalls of Getinge and Maquet’s VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems and BD’s Alaris Pump Module model 810 as Class 1, the most severe category indicating serious risk of injury or death.

According to FDA’s July 15 announcement, the vessel harvesting system recall was issued due to the possibility of two failure modes: a bent or detached heater wire and silicone peeling or detaching from the jaws of the harvesting tool. Potential health consequences include bleeding, burns, injury, blood vessel embolism or occlusion, infection, and death. There have been zero reports of death and seven reports of injuries, four for the heater wire and three for silicone peeling or detaching.

In response, the manufacturer sent advisory letters to customers and updated the devices instructions for use. FDA’s recall announcement advises reviewing those instructions, as well as a separate letter to healthcare providers related to the recall. The full announcement offers additional detail and context, including instructions from the manufacturer, images of the heater wire and silicone detachment, and more. 

As for the Alaris Pump Module model 8100 recall, BD and subsidiary CareFusion issued a letter notifying customers of potentially worse performance when used with a subset of compatible pump infusion sets. Specifically, “BD stated that they have identified a subset of compatible pump infusion sets that may perform outside the performance ranges published in the User Manuals for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolus volume (POBV),” FDA reports.

Variations in pump performance are most common at programmable rates under 1 mL/h and at or under 1 mL of volume and when infused through the affected subset of compatible infusion sets. This can result in overinfusion, underinfusion, or alarm delays, which, depending on the case, could pose risks to patients ranging from missed or delayed treatments to acute toxicity and overdose. The full FDA announcement provides an overview of six potential impacts on infusion delivery, as well as data on performance ranges and instructions and contact information for users. No injuries or deaths had been reported as of July 11.