Recall Z-0257-2025— Covidien LP
Class II · Ongoing
Class II FDA medical device recall by Covidien LP, initiated 2024-09-19. It names one FDA 510(k) clearance: K163231. 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). Reason: Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing..
- Recalling firm
- Covidien LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-19
- Firm location
- Mansfield, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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)
Reason for recall
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.