Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm — Class II medical device recall Z-0557-2022
Ongoing recall by Covidien Llc, reported 2022-02-09, distributed nationwide. The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon prot
| Recall number | Z-0557-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2021-12-17 |
| Classified | 2022-02-03 |
| Reported by FDA | 2022-02-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, CN, DE, ES, IL, IT, PT, SG |
| Quantity | 1,994 devices |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 07290016745047, 10884521812253, 10884521812291 |
| Lot numbers | 21904374, 21904432, 22000673, 22000709, 22000817, 22000880, 22001030, 22001061, 22001191, 22001310, 22001417, 22001448, 22001728, 22002086, 22002088, 22002498, 22002583, 22002603, 22003037, 22100003, 22100321, 22100322, 22101089, 22101090, 22102189 |
Product
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Reason for recall
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
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-0557-2022. 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.