Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
Micro Therapeutics
7 recalls • • Categories: Other Medical Devices, Diagnostic Equipment, Surgical Instruments
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
European version of microcatheter were distributed within US which contain a different "Indications for Use".
European version of microcatheter were distributed within US which contain a different "Indications for Use".
Class I - Dangerous
Outer carton packaging of microcatheters were exposed to wet substance during transport.
Class I - Dangerous
Outer carton packaging of microcatheters were exposed to wet substance during transport.
Class I - Dangerous
Due to incorrect size and configuration labeling of the detachable coil system.