🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: December 14, 2018 BrosMed Medical Co.,Ltd. Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BrosMed Medical Co.,Ltd.
Reason for Recall:
Incorrect (higher) Rated Burst Pressure information printed on label.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.

Distribution:

Distributed in: US, MO

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0963-2019