VIA 27 Microcatheter — Class II medical device recall Z-0114-2017
Terminated recall by Sequent Medical Inc, reported 2016-11-02, distributed in CA, FL, KS, MD, MN, MO, NC, NY…. Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the intervention
| Recall number | Z-0114-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sequent Medical Inc, Aliso Viejo, CA, United States |
| Recall initiated | 2016-09-23 |
| Classified | 2016-10-27 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2017-05-01 |
| Distributed | CA, FL, KS, MD, MN, MO, NC, NY, OH, TN, WV |
| Countries outside the US | CH, CZ, DE, DK, ES, FI, FR, GB, HU, IE, IT, NL, SI, TR |
| Quantity | 618 units |
| Model numbers | FG27-154-01, VIA-27-154-01 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0114-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.