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Ezdilate balloon dilators

Official notice

4 Dec 2023

Last checked

4 Dec 2023

Medium riskHealth Canada
Watch Gyrus Acmi

An official Health Canada notice concerns Ezdilate balloon dilators. 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 Published 2023-12-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74670

Official notice

2023-12-04

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

74670

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Affected products

Product 1

Affected products - EZDilate Balloon Dilator (FW), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - BD- 400P-1580 BD-400P-1080 BD-400P-1380 BD-400P-2080

Product 2

Affected products - EZDilate Balloon Dilator (WG), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - BD-410X-2055 BD-410X-1855 BD-410X-0855 BD-410X-1555 BD- 410X-1355 BD-410X-1055

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Gyrus Acmi, Ezdilate Balloon Dilators

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi, Ezdilate Balloon Dilators.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74670

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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