EZDilate Balloon Dilators
Brand(s)
Last updated
Summary
Product
EZDilate Balloon Dilators
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| EZDilate Balloon Dilator (FW) | More than 10 numbers, contact manufacturer. | BD- 400P-1580 BD-400P-1080 BD-400P-1380 BD-400P-2080 |
| EZDilate Balloon Dilator (WG) | More than 10 numbers, contact manufacturer. | BD-410X-2055 BD-410X-1855 BD-410X-0855 BD-410X-1555 BD- 410X-1355 BD-410X-1055 |
Issue
Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving the devices, as well as reports of bursting and leaking. Olympus has received reported adverse events involving foreign body in patient and prolonged procedure.
Recall Start Date: November 21, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies
Gyrus Acmi, Inc
9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74670
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