Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm — Class II medical device recall Z-0257-2025
Ongoing recall by Covidien LP, reported 2024-11-06, distributed nationwide. Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
| Recall number | Z-0257-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, Mansfield, MA, United States |
| Recall initiated | 2024-09-19 |
| Classified | 2024-10-29 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CN, DE, ES, FR, GR, IE, IL, IN, IT, JP, NL, PT, SG, TR |
| Quantity | 16,336 units |
| UPC / GTIN / UDI-DI | 10884521812260, 10884521812277, 10884521812284, 10884521812291, 10884521812307, 10884521812314, 10884521812321 |
| Lot numbers | 10MM, 22200635, 22201015, 22201046, 22201047, 22201087, 22201337, 22201364, 22201391, 22201424, 22201425, 22201785, 22201786, 22201813, 22201814, 22201871, 22201872, 22201897, 22201908, 22202144, 22202145, 22202223, 22202412, 22202413, 22202426, 22202427, 22202428, 22202611, 22202612, 22202644, 22202645, 22202646, 22202781, 22202800, 22202801, 22202802, 22203008, 22203009, 22203026, 22203040 and 80 more |
| Serial numbers | 12MM, 22200739, 22201815, 22202176, 22202177, 22202212, 22202213, 22202643, 22202799, 22203025, 22300000, 22300300, 22300969, 22301117, 40MM, 6MM, 75CM |
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 for recall
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0257-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.