Recall Z-0114-2017— Sequent Medical Inc

Name: FDA recall Z-0114-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-23

Class II · Terminated

Class II FDA medical device recall by Sequent Medical Inc, initiated 2016-09-23, terminated 2017-05-01. It names one FDA 510(k) clearance: K132652. 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).. Reason: Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed..

Recalling firm: Sequent Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-23
Terminated: 2017-05-01
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132652 — VIA MICROCATHETER, VIA PLUS MICROCATHETERSequent Medical, Inc.·cleared 2013-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.