Recall Z-0225-2025 · FGE Stents, Drains And Dilators For The Biliary Ducts
Olympus Corporation of the Americas
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055
| Date | Oct 25, 2024 (initiated Sep 13, 2024) |
| Status | Open, Classified |
| Reason | Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch |
| Root cause | Under Investigation by firm |
| Action | Olympus issued Urgent Medical Device Removal letter issued 9/13/24 to Endoscopy Department, Risk Management Department. Letter states reason for recall, health risk and action to take: 2. Examine your inventory and identify the above-listed device with the affected batch number. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. When it is received, you will receive a credit for your affected device(s). 4. If you have further distributed this product, identify your customers, |
| Quantity | 209 units |
| Distribution | Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter Gyrus Acmi, Inc., Mar 8, 2018 |