EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in
Summary
The FDA issued a Class II for EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation by Olympus Corporation of the Americas. Reason: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patie.
Details
Source
Device Recall
External ID
Z-0942-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
Lot/Code Info: UDI-DI: 00821925033252 Lot Numbers: 372741, 373098, 373607, 378931, 378932, 380775, 380776, 387128, 388778, 388779, 389197, 389201
Quantity Affected: 3767 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-10
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0942-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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