Covidien LP: Device Recall
Recall #Z-0257-2025 · 09/19/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0257-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Covidien LP
- Status
- Ongoing
- Date Initiated
- 09/19/2024
- Location
- Mansfield, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,336 units
Reason for Recall
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Product Description
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)
Distribution Pattern
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.
Other Recalls by Covidien LP
- Class II: Risk 09/25/2025
- Class II: Risk 09/25/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.