Health product recall

EZDilate Balloon Dilators

Brand(s)
Last updated

Summary

Product
EZDilate Balloon Dilators
Issue
Medical devices - Performance issue
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