Class II — BrosMed Medical Co.,Ltd.
| Recalling firm | Brosmed Medical Co.,Ltd |
|---|---|
| Registered facility | BROSMED MEDICAL CO.,LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect (higher) Rated Burst Pressure information printed on label. |
| Product | Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature. |
| Quantity | 400 |
| Distribution | US Distribution to MO. |
| Initiated | 2018-12-14 |
| Classified | 2019-02-27 |
| Terminated | 2020-12-11 |
| Recall number | Z-0963-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BrosMed Medical Co.,Ltd. (Z-0963-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81973/
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