Covidien LP Recall 95447
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)
Covidien LP Recall 95447 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0257-2025 |
| Event ID | 95447 |
| Event 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) |
| Product Type | Devices |
| 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. |
| Quantity | 14,510 units |
| Recall Reason | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. |
| Device Classification | 20241106 |
| Device Code Info | 5mm x 40mm x 75cm (CFN CH05-40-75US): UDI-DI: 10884521812260; Lot Numbers: 22201047, 22201424, 22201425 22202802, 22203008, 22203009 22203040, 22300536, 22300970 22300971, 22301116, 22301270 22400129, 22400572, 22400573; 6mm x 40mm x 75cm (CFN CH06-40-75US): UDI-DI: 10884521812277; Lot Numbers: 22201337, 22201908, 22202412 22202413, 22202611, 22202612 22202801, 22300151, 22300318 22300319, 22300320, 22300862 22300965, 22301285, 22301494 22301661, 22301895, 22301896 22302180, 22400243, 22400244 22400574, 22400576; 7mm x 40mm x 75cm (CFN CH07-40-75US): UDI-DI: 10884521812284; Lot Numbers: 22200635, 22201897, 22202223 22202426, 22202427, 22202800 22203055, 22300321, 22300864 22301028, 22301648, 22301649 22301889, 22301890, 22302033 22302034; 8mm x 40mm x 75cm (CFN CH08-40-75US): UDI-DI: 10884521812291; Lot Numbers: 22201015, 22201046, 22201087 22201785, 22201786, 22201813 22202144, 22202145, 22202644 22202645, 22300165, 22300230 22300534, 22300535, 22300876 22300877, 22300966, 22301133 22301134, 22301299, 22301495 22302032, 22400154, 22400164 22400165; 9mm x 40mm x 75cm (CFN CH09-40-75US): UDI-DI: 10884521812307; Lot Numbers: 22201364, 22202428, 22203026 22300152, 22300539, 22301123 22301124, 22400698, 22400699 22400858; 10mm x 40mm x 75cm (CFN CH10-40-75US): UDI-DI: 10884521812314; Lot Numbers: 22201814, 22201871, 22202646 22300185, 22300219, 22300231 22300863, 22301300, 22301301 22302026, 22302031, 22302044 22400153, 22400247; 12mm x 40mm x 75cm (CFN CH12-40-75US): UDI-DI: 10884521812321; Lot Numbers: 22201391, 22201872, 22202781 22300301, 22300302, 22300878 22300967, 22300968, 22301269 22400128, 22400279 |
| Center Classification Date | 20241029 |
| Recall Initiation Date | 20240919 |
| Recalling Firm | Covidien LP |
| Initial Notification | Letter |
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