EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Reported: February 7, 2024 Initiated: November 10, 2023 #Z-0934-2024
Product Description
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Reason for Recall
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 1796 units
- Distribution
- Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080. Recalled by Olympus Corporation of the Americas. Units affected: 1796 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0934-2024.
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