W.L. Gore and Associates recently announced the voluntary product recall of its Molding and Occlusion Balloon (MOB) Catheters.
The Newark, Delaware-based manufacturing company issued the warning due to complaints of leakage from the guidewire lumen and the y-hub during the preparation or use of the MOB catheters. The issue could result in insufficient inflation or an inability to inflate, according to the warning letter.
Gore has received 75 complaints regarding the catheter. Of those complaints, all but one reported the MOB catheters being used for molding purposes. The remaining complaint reported the device being used as a temporary occlusion device for an emergent procedure. There have been no reports of immediate or long-term health consequences as a result of the device.
The company said the source of the device failure is due to a manufacturing equipment change.
The recall affects devices that have an expiration date between December 7, 2022, and May 5, 2023. Affected catalog numbers include MOB 36 and GTIN/UDI-DI 00733132639489. MOB37 devices with serial numbers between 22982051 and 23516741 are also affected by the recall.
In clinical use scenarios, increased procedure time to obtain an alternative device is most likely. When the MOB devices are used for occlusion, the increased procedure time could be associated with critical blood loss and result in life-threatening patient harm, according to the company.
Patient harm while using the device could also result in cases of emergent rupture, the device not being prepared using included instructions for use, a lack of readily available additional occlusion balloons and inability to convert to open surgery.
To mitigate risk, Gore is recommending firms inspect product inventories and remove and return any affected devices.
Gore’s MOB catheters are intended for use in the temporary occlusion of large diameter vessels to assist the expansion of self-expanding endovascular prostheses, also known as stent grafts or molding.