InstaClear Sheath
Brand(s)
Last updated
Summary
Product
InstaClear Sheath
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| InstaClear Sheath | All lots. | LCS4K00UNOL LCS1830BTST LCS1500UNOL LCS4K45TPOL LCS4K70BTOL LCS1800UNST LCS4K70TPOL LCS4K30TPOL LCS1570TPOL LCS4K30BTOL LCS1530TPOL LCS1530BTOL LCS1830TPST |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Gyrus Acmi, Inc
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75529
Get notified
Receive notifications for new and updated recalls and alerts by category.