Single Use Ligating Device PolyLoop™
Brand(s)
Last updated
Summary
Product
Single Use Ligating Device PolyLoop™
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78470
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