Recall Monitor
Health Products

Single Use Ligating Device PolyLoop™

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: Single Use Ligating Device PolyLoop™
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Single Use Ligating Device PolyLoop™All lots.HX-400U-30

Issue

Olympus received complaints indicating that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy. Users are reminded to adhere to the warnings and cautions statements that are present in the instructions for use.

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