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Terminated

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).

FDA Recall Z-0114-2017 · Posted 2016-10-27

Recalling FirmSequent Medical Inc
Recall StatusTerminated
Product CodeKRA
Date Initiated2016-09-23
Date Terminated2017-05-01
Product Quantity618 units

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.

Firm Action

Sequent Medical sent an Urgent Medical Device Recall letter dated September 23, 2016, to all affected customers. The letter informed customers that Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. The letter informs the customers of the risk to health and actions to be taken. Customers were instructed to send all confirmation forms and questions to [email protected]. Customers with questions should call (949) 830-9600x130. For questions regarding this recall call 949-923-9400.

Root Cause

Under Investigation by firm

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132652VIA MICROCATHETER, VIA PLUS MICROCATHETERSequent Medical, Inc. · 2013-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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