Olympus Recalls Ligating Device Due to Detachment Issues
This recall was posted 3 months ago. Check the FDA source for the latest status.
Class I Recall — Most Serious
This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.
Olympus Corporation has issued a voluntary recall for its Single-Use Ligating Device, known as the Polyloop, due to potential safety concerns. The device, used with Olympus endoscopes to control bleeding after polypectomy, may fail to detach as expected, leading to it becoming anchored to patient anatomy.
Products Affected:
- Single-Use Ligating Device (Polyloop) by Olympus
Reason for Recall:
The recall was initiated after reports indicated that the Polyloop device might not release properly, posing risks such as bleeding, mucosal injury, perforation, and in severe cases, the need for surgical intervention. No deaths have been reported.
What Consumers Should Do:
- Ensure all personnel are familiar with the updated guidance and emergency procedures.
- Acknowledge receipt of the recall notice on the Olympus recall web portal using recall number "0476".
- Report any adverse reactions or quality issues to the FDA's MedWatch program.
- Contact Olympus Technical Assistance Center at 1-800-848-9024, Option 1, or email [email protected] for more information.
Consumers are advised to stay informed and follow the instructions provided to ensure safety and compliance.
Where Products Were Sold
This recall affects products distributed nationwide across the United States.
Contact Information
Media Contact
Susan Scerbo