Covidien LP recalls Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-

Recalled November 6, 2024 · FDA recall Z-0257-2025 · Covidien

Hazard

Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. · FDA Class II

Units

16,336 units

Sold at

Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain and Turkey.

Description

Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.

Product

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)

Manufacturer(s)

Covidien LP

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →