Product Wiki · Recalls · Health Canada — Medical Devices

Endocuff Vision (2020-04-16) — recall 61223

Health Canada — Medical Devices · Canada · 2020-05-08 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
61223
Date of alert
2020-05-08
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Boddingtons, the manufacturer is notifying customers regarding the update to an IFU for Endocuff Vision model numbers ARV110, ARV120, ARV130, and ARV140. The new IFU will include the following information relating to contraindications and potential complications/adverse events of the colonoscopy procedure. Contraindication: the Endocuff Vision should not be used in cases with acute, severe colitis, diverticulitis or where there is known colonic stricture. Potential complication or adverse events: no common adverse events or complications for Endocuff Vision are known. However, potential complications related to colonoscopy include, but are not limited to perforation, bleeding, infection, discomfort and allergic reaction to sedation agents. Boddingtons has determined that customers may continue to use products on hand provided users are aware of the updated information. The updated IFU will accompany new products starting in May 2020.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/endocuff-vision-2020-04-16

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