Events

Recall of 7F NeuroFlo Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ZOLL Circulation, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69735
  • Event Risk Class
    Class 2
  • Event Number
    Z-0477-2015
  • Event Initiated Date
    2014-04-01
  • Event Date Posted
    2014-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131443
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, neuro-vasculature, occluding balloon - Product Code PAV
  • Reason
    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.
  • Action
    Hospital was notified in April 2014 of the recall by UPS.

Device

7F NeuroFlo Catheter
  • Model / Serial
    Model 1027, Catalog number 8700-000775-01, lot 0021.
  • Product Classification
    Neurological Devices
  • Device Class
    HDE
  • Implanted device?
    No
  • Distribution
    One location in NC
  • Product Description
    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.
  • Manufacturer
    ZOLL Circulation, Inc.

Manufacturer

ZOLL Circulation, Inc.
  • Manufacturer Address
    ZOLL Circulation, Inc., 2000 Ringwood Ave, San Jose CA 95131-1728
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA