Olympus Corporation of the Americas Recall 93508
Description: EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
Olympus Corporation of the Americas Recall 93508 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0939-2024 |
| Event ID | 93508 |
| Event Description | EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855 |
| Product Type | Devices |
| Distribution | Nationwide. Foreign: AU BR BR CA DE HK IN JP SG |
| Quantity | 1639 units |
| Recall 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. |
| Device Classification | 20240207 |
| Device Code Info | UDI-DI: 00821925033221 Lot Numbers: 373808, 374005, 379746, 379747, 379835, 379836, 381157 |
| Center Classification Date | 20240131 |
| Recall Initiation Date | 20231110 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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