Recall Z-0940-2024 · FGE Stents, Drains And Dilators For The Biliary Ducts
Olympus Corporation of the Americas
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
| Date | Jan 31, 2024 (initiated Nov 10, 2023) |
| Status | Open, Classified |
| Reason | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Root cause | Process control |
| Action | Olympus issued Urgent Medical Device Removal Letter on 11/10/23. Firm issued a Correction letter dated December 1, 2023 to the letter of November 10, 2023 including Additional Lot numbers . Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any models and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lots. Any models and lots that are not impacted can remain in inventory and be used. The model/lot number can be f |
| Quantity | 2991 units |
| Distribution | Nationwide. Foreign: AU BR BR CA DE HK IN JP SG |
| 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 |