Class 2 Device Recall Hermes NC PTA Balloon Dilation Catheter

• Date Initiated by Firm: December 14, 2018
• Create Date: February 27, 2019
• Recall Status: Terminated on December 11, 2020
• Recall Number: Z-0963-2019
• Recall Event ID: 81973
• 510(K)Number: K160941
• Product Classification: Catheter, angioplasty, peripheral, transluminal - Product Code LIT
• 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.
• Code Information: Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
• FEI Number: 3010391265
• Recalling Firm/ Manufacturer: BrosMed Medical Co.,Ltd.; Bubugaogaofu Lou Lou 15th; Songshan Lake Hi; Dongguan China
• Manufacturer Reason for Recall: Incorrect (higher) Rated Burst Pressure information printed on label.
• FDA Determined Cause: Employee error
• Action: On December 7, 2018 the firm, BrosMed Medical, sent an "URGENT FIELD SAFETY NOTICE" dated December 7, 2018 to their consignee. The notice described the product, problem and actions to be taken. The consignee was instructed to do the following: " Please reference the Attachment 1 for the list of Hermes NC PTA Balloon Dilatation Catheter with affected catalogue numbers and lots numbers. . Immediately stop selling the device from these lots. " Transfer this notification and inform relevant distributors/hospitals/clinics to check their inventory, complete and return the Effectiveness Check form in attachment 2 to you, and return the affected unused Identified Hermes NC PTA Balloon Dilatation Catheters back to your warehouse, if any. " Please help collect the unused identified Hermes NC PTA Balloon Dilatation Catheters from relevant distributors/hospitals/clinics to your warehouse as well collect the Effectiveness Check Forms. " Review your inventory, complete the Effectiveness Check Forms in attachment 2 to BrosMed Medical and return all unused identified products including the collections in your warehouse to BrosMed Medical, if any . This action does not affect patients having successfully undergone interventional procedures using these devices. What is BrosMed Medical doing? BrosMed Medical has already implemented corrective actions to ensure ongoing product performance. BrosMed Medical will work with you to replace the return units with similar products. The appropriate regulatory agencies have been notified of this action. If you have any question, please do not hesitate to contact BrosMed Medical: E-mail: cs@brosmed.eu at Tel: +31850140 901.
• Quantity in Commerce: 400
• Distribution: US Distribution to MO.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = LIT