Sequent Medical Inc: Medical Device Recall in 2016 - (Recall #: Z-0114-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: September 23, 2016

Date Posted: November 2, 2016

Recall Number: Z-0114-2017

Event ID: 75211

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.

Status: Terminated

Product Quantity: 618 units

Code Information:

16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701

Distribution Pattern:

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,

Voluntary or Mandated:

Voluntary: Firm initiated