Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1397-2020 — MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the ne

U.S. FDA — Device Enforcement · United States · 2019-11-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1397-2020
Date of alert: 2019-11-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Microvention, Inc.
Product category: device
Product type: Devices

Reported risk: The devices may be missing the implant coil.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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