Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilat...
FDA Recall #Z-0963-2019 — Class II — December 14, 2018
Product 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.
Reason for Recall
Incorrect (higher) Rated Burst Pressure information printed on label.
Recalling Firm
BrosMed Medical Co.,Ltd. — Dongguan
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
400
Distribution
US Distribution to MO.
Code Information
Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated