Class 2 Device Recall 7F NeuroFlo Catheter

• Date Initiated by Firm: April 01, 2014
• Date Posted: December 03, 2014
• Recall Status: Terminated on November 26, 2014
• Recall Number: Z-0477-2015
• Recall Event ID: 69735
• HDE Number: H030005
• Product Classification: Catheter, neuro-vasculature, occluding balloon - Product Code PAV
• Product: 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.
• Code Information: Model 1027, Catalog number 8700-000775-01, lot 0021.
• Recalling Firm/ Manufacturer: ZOLL Circulation, Inc.; 2000 Ringwood Ave; San Jose CA 95131-1728
• For Additional Information Contact: James Palazzolo; 408-541-2913
• Manufacturer Reason for Recall: After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.
• FDA Determined Cause: Other
• Action: Hospital was notified in April 2014 of the recall by UPS.
• Quantity in Commerce: 1 device
• Distribution: One location in NC
• 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.

• HDE Database: HDEs with Product Code = PAV