Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter Recalled by BrosMed Medical Co.,Ltd. Due to Incorrect (higher) Rated Burst Pressure information printed on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BrosMed Medical Co.,Ltd. directly.
Affected Products
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
Why Was This Recalled?
Incorrect (higher) Rated Burst Pressure information printed on label.
Where Was This Sold?
This product was distributed to 1 state: MO
About BrosMed Medical Co.,Ltd.
BrosMed Medical Co.,Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report