Sequent Medical Inc recalls VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of n

Recalled November 2, 2016 · FDA recall Z-0114-2017 · Sequent Medical

Hazard

Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. · FDA Class II

Units

618 units

Sold at

Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,

Description

Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.

Product

VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).

Manufacturer(s)

Sequent Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →