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Exalt model d single-use duodenoscope

Official notice

18 Oct 2023

MediumHealth Canada

An official Health Canada notice concerns Exalt model d single-use duodenoscope. Boston Scientific Corporation (BSC) is initiating a removal of specific batches of Exalt Model D Single-Use Duodenoscopes that were manufactured with an alternate imager configuration. BSC has received an increase in complaints for poor quality image due to fluid ingress in the lens. Recall Start Date: October 3, 2023 Published 2023-10-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74439

Official notice

2023-10-18

The hazard

Boston Scientific Corporation (BSC) is initiating a removal of specific batches of Exalt Model D Single-Use Duodenoscopes that were manufactured with an alternate imager configuration. BSC has received an increase in complaints for poor quality image due to fluid ingress in the lens. Recall Start Date: October 3, 2023

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74439

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Affected products

Product 1

Affected Products - Exalt Model D Single-Use Duodenoscope, Lot or serial number - More than 50 numbers, contact manufacturer., Model or catalog number - M00542420 M00542421

Risk / hazard

Boston Scientific Corporation (BSC) is initiating a removal of specific batches of Exalt Model D Single-Use Duodenoscopes that were manufactured with an alternate imager configuration. BSC has received an increase in complaints for poor quality image due to fluid ingress in the lens. Recall Start Date: October 3, 2023

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific, Exalt Model D Single-use Duodenoscope.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74439

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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