Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation… — Class II medical device recall Z-0963-2019
Terminated recall by BrosMed Medical Co.,Ltd., reported 2019-03-06. Incorrect (higher) Rated Burst Pressure information printed on label.
| Recall number | Z-0963-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BrosMed Medical Co.,Ltd., Dongguan, China |
| Recall initiated | 2018-12-14 |
| Classified | 2019-02-27 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2020-12-11 |
| Quantity | 400 |
| Reason classes | labeling |
| Lot numbers | F1800580, F1800581, F1800582, F1800583, F1800584, F1800585, F1804186, F1804187, F1804188, F1804189 |
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.
Reason for recall
Incorrect (higher) Rated Burst Pressure information printed on label.
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-0963-2019. 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.