Merit Medical Systems Recalls Hemostasis Valves in Europe

Merit Medical Systems has recalled some of its Access-9 and AccessPLUS hemostasis valves in Europe.

The reason for the recall is a defect arising from a recent design change made to improve manufacturability, the South Jordan, Utah-based company said.  The affected valves have an internal gap between the rotator and the Y-body where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device.

The company said it received 17 complaints, although no reports of injuries or deaths so far. The problem affects 120 lots of the devices.

The defect “does not appear to affect the safety or performance of the device when used as intended, but the potential of kinking or damaging the wire remains a possibility if the wire meets resistance and is advanced with extra manipulation or effort,” the company said.