Recall Z-0257-2025 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Covidien LP
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)
| Date | Oct 29, 2024 (initiated Sep 19, 2024) |
| Status | Open, Classified |
| Reason | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. |
| Root cause | Under Investigation by firm |
| Action | An "URGENT: MEDICAL DEVICE RECALL" notification letter dated September 2024 was sent to customers. Required Actions: 1. Quarantine and discontinue use of unused affected product lot numbers immediately (see Attachment A). 2. Return all unused products from your inventory to Medtronic. Please contact: rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). a. Credit for the returned affected product will be issued based on the RGA number. b. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your |
| Quantity | 16,336 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163231 | Chameleon PTA Balloon Catheter Av Medical Technologies, Ltd., Jan 17, 2017 |