Z-0114-2017Class II

VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the...

Name: Z-0114-2017 VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the...
Creator: Sequent Medical Inc
Published: 2016-09-23
License: https://open.fda.gov/license/

Sequent Medical, Inc. / initiated 2016-09-23 / Terminated

FDA source

Sequent Medical Inc began a recall of 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... on 2016-09-23. FDA classified it as Class II and gives the reason as "Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0114-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-23
Posted: 2016-10-27
Terminated: 2017-05-01
Recalling firm: Sequent Medical, Inc.
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).
Product code: KRA Catheter, Continuous Flush
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 618 units
Distribution: 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,
Product codes and lots: 16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0114-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0114-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-27

Product code KRA

K132652Class IIVia Microcatheter, via Plus MicrocatheterSequent Medical, Inc. / cleared 2013-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)