Terumo (TYO:4543) subsidiary MicroVention issued an urgent field safety notice to warn of a number of its Azur endovascular embolization products that may be missing the implant coil.
Affected products include certain lots of the Azur peripheral coil system detachable 18 and the Azur peripheral coil system detachable 35, according to the notice out of Germany.
The Azur system is designed to reduce or block the rate of blood flow in vessels of the peripheral vasculature in interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
MicroVention said it received 15 complaints regarding devices missing the implant coil. However, no adverse events have been reported in the related devices.
The company added that a device with a coil may still be used, but one missing the implant coil should not be used and a replacement device should be obtained.
Original Article: (https://www.massdevice.com/microvention-issues-safety-notice-for-azur-endovascular-embolization-products/)