Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm Recalled by Covidien LP Due to Specific lots of the Chameleon PTA Balloon Catheter...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien LP directly.
Affected Products
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)
Quantity: 16,336 units
Why Was This Recalled?
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien LP
Covidien LP has 57 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report