Official recall record

InstaClear Sheath

Health Canada — Medical Devices · 2024-05-17 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-05-17
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Olympus (Gyrus Acmi, Inc.) is initiating a medical device recall action after investigating a complaint for an InstaClear Sheath (model # LCS4K30BTOL) in which the plate on the distal end of the sheath broke off during a procedure. Olympus has received sixty-seven (67) complaints across all sheath models related to breakage or damage to the pin or plate at the distal end of the InstaClear Sheath since the product was launched in 2016. Four (4) complaints were reported as serious injuries. Recall Start Date: May 3, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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