Micro Therapeutics Recalls Embolization Device

Medtronic’s Micro Therapeutics unit has recalled (Class 1) its Pipeline Vantage Embolization Device with Shield Technology after it determined that the use of the embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and braid deformation. A recall notice says that these adverse events were seen during procedure and post-procedure, typically noted at a 6-12 month imaging follow-up. If the braid deformation occurs, this could potentially lead to thrombosis and serious adverse events, the notice says, adding that there is higher risk in females aged 45 years or younger.

The company says the flow-diverting implant is used to treat aneurysms. It diverts blood flow away from the aneurysm in the neck and reconstructs the parent artery. The device’s Shield Technology surface coating reduces thrombogenicity and improves hemocompatibility, it says.