Class II

Medical Device Recall: EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380

Olympus Corporation of the Americas · November 10, 2023

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.

Distribution

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

States Affected

NATIONWIDE

Quantity Affected

1008 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0935-2024

Status: ongoing

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