CanadaCleverCut and FlowCut sphincterotomes (Olympus Medical Systems Corp.) — including Disposable Triple Lumen Sphincterotome and Sphincterotome models KD-V411M-0725, KD-V431M-0720, KD-411Q-0730, KD-V431M-0730, KD-V411M-0320, KD-V411M-0730, KD-V411M-0330, KD-V411M-0720, KD-VC411Q-0320, KD-VC411Q-0720, KD-VC433Q-0730, KD-VC412Q-0215, KD-VC431Q-0720, KD-VC411Q-0330 and KD-VC433Q-0720 — with lot or serial numbers more than 10 digits may be affected. Olympus is removing lots because devices that did not undergo thermoforming could deform and lose performance. Users should stop using affected devices and contact the manufacturer/customer service to return the product or for more information.
What's being recalled
Companies: Olympus Medical Systems Corp., 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507.
How to identify it
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-V411M-0725
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-V431M-0720
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-411Q-0730
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-V431M-0730
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-V411M-0320
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-V411M-0730
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-V411M-0330
Affected products: Disposable Triple Lumen Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-V411M-0720
Affected products: Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-VC411Q-0320
Affected products: Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-VC411Q-0720
Affected products: Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-VC433Q-0730
Affected products: Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-VC412Q-0215
Affected products: Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-VC431Q-0720
Affected products: Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-VC411Q-0330
Affected products: Sphincterotome; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: KD-VC433Q-0720
The hazard
CleverCut and FlowCut sphincterotome devices which did not undergo thermoforming could deform and lose performance. Olympus is removing lots where the devices may not have been manufactured with the thermoforming process. Users are to cease usage and contact customer service to return their affected product.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)