EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Reported: February 7, 2024 Initiated: November 10, 2023 #Z-0943-2024
Product Description
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
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
- 4182 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 Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855. Recalled by Olympus Corporation of the Americas. Units affected: 4182 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-0943-2024.
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