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Instaclear sheath
Official notice
17 May 2024
Last checked
17 May 2024
An official Health Canada notice concerns Instaclear sheath. 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 Published 2024-05-17.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75529
Official notice
2024-05-17
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Gyrus Acmi, Instaclear Sheath.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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