Olympus recalls CleverCut Single Use 3-Lumen Sphincterotome V (model KD-V411M-0320) due to potential deformation if not properly thermoformed, affecting medical use.
Devices which did not undergo thermoforming could deform and lose performance.
Olympus recalls CleverCut Single Use 3-Lumen Sphincterotome V devices that may deform and lose performance if not properly thermoformed. This could impact medical procedures requiring precise instrument function.
The devices require thermoforming to maintain proper shape and function. If not thermoformed correctly, they may deform and lose performance during medical procedures, potentially affecting precision.
Medical professionals using the CleverCut Sphincterotome V for endoscopic procedures are most at risk. Patients using these devices during papillotomy may be affected if the instrument deforms.
Check for model number KD-V411M-0320 on the device. The product was sold with valid expiration dates and includes specific material references.
Look for model number KD-V411M-0320 on the device to confirm if it is recalled.
The recall states devices that did not undergo thermoforming could deform and lose performance, so proper thermoforming is required for safe use.
The recall does not specify a remedy, so no action is required beyond checking if the device was properly thermoformed.
Check for model number KD-V411M-0320 on the device. The product was sold with valid expiration dates and includes specific material references.
We’ve drafted a message you can send CleverCut to request your refund or repair — edit it as you like.
Subject: Recall Z-1268-2026 — CleverCut CleverCut Hello, I own a CleverCut that is covered by recall Z-1268-2026 from CleverCut. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
