Olympus Corporation of the Americas Recall 93508
Description: EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
Olympus Corporation of the Americas Recall 93508 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0933-2024 |
| Event ID | 93508 |
| Event Description | EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880 |
| Product Type | Devices |
| Distribution | Nationwide. Foreign: AU BR BR CA DE HK IN JP SG |
| Quantity | 126 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: 00821925033160 Lot Number: 380777 |
| Center Classification Date | 20240131 |
| Recall Initiation Date | 20231110 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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