InstaClear Sheath
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
InstaClear Sheath |
All lots. |
LCS4K00UNOL |
Issue
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
Additional information
Details
Gyrus Acmi, Inc
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
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