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Exalt Model D Single-Use Duodenoscope — recall 74439

Health Canada — Medical Devices · Canada · 2023-10-18 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 74439
Date of alert: 2023-10-18
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Gastroenterology and urology
Product type: Medical devices

Reported risk: 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

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/exalt-model-single-use-duodeno

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Exalt Model D Single-Use Duodenoscope — recall 74439

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