CleverCut and FlowCut Sphincterotomes
Brand(s)
Last updated
Summary
Product
CleverCut and FlowCut Sphincterotomes
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 catalogue number |
|---|---|---|
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0725 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V431M-0720 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-411Q-0730 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V431M-0730 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0320 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0730 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0330 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0720 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC411Q-0320 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC411Q-0720 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC433Q-0730 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC412Q-0215 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC431Q-0720 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC411Q-0330 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC433Q-0720 |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General and plastic surgery
Companies
| Olympus Medical Systems Corp. |
| 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81525
Get notified
Receive emails about new and updated recall and safety alerts.