Merit Medical (Nasdaq:MMSI) issued an urgent field safety notice in Europe to alert users to a recall of some of its hemostasis valves.
South Jordan, Utah-based Merit initiated the voluntary recall of its Access-9 and AccessPLUS hemostasis valves as a result of a defect relating to a recent design change made to improve manufacturability, according to the notice.
Access hemostasis valves manufactured after the implementation of the change have an internal gap between the rotator and Y-body where the guidewire can get caught, Merit said. This can result in difficulty advancing the guidewire through the device.
Merit said the recall affects 120 Merit lots and 61 Merit catalog numbers, although the issue is unlikely to cause harm to the patient and does not result in additional risk to the patient or user.
Additionally, 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, potentially resulting in the delay of a procedure.
The company has not received reports of patient harm or injury related to the issue, but as of the date of the letter (issued March 4, 2022), Merit received 17 customer complaints related to the issue, leading the company to choose to remove the units from the market and request the immediate cessation of use or distribution.