Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm Recalled by Covidien Llc Due to Foreign Object Contamination
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 Llc directly.
Affected Products
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Quantity: 1,994 devices
Why Was This Recalled?
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien Llc
Covidien Llc has 59 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report