Events

Recall of Device Recall Integra NeuroSensor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra Neuro Sciences.

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
    46788
  • Event Risk Class
    Class 2
  • Event Number
    Z-1191-2008
  • Event Initiated Date
    2008-01-28
  • Event Date Posted
    2008-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68272
  • 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
    intracranial pressure probe - Product Code GWM
  • Reason
    Incorrect pressure reading: due to a manufacturing error, the icp reading could be inaccurate to the extent that they exceed label claims. specifically, the insertion error label claim of +/- 3mmhg could be exceeded by up to -3mmhg, that could result in a maximum insertion error of +/- 6mmhg.
  • Action
    Integra NeuroSciences sent a Recall Notification with a Recall Acknowledgement form to all customers with product currently in their possession through an Integra Field Sales Repesentative on January 28, 2008. The notification advises that the firm has determined that due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg that could result in a maximum Insertion Error of +/- 6mmHg. Customers are asked to examine their inventory immediately to determine if they have any NeuroSensor Model NS-P's lot #100063 on hand and if so to not use the product. Customers are advised to contact their local Integra representative for further assistance. The letter advises that the lot/serial number is located on a white 1/2" x 1/2" label on the large beige optical connector, and can readily be seen through the bottom of the product tray packaging. The letter also advises that this recall pertains to NeuroSensor Model NS-P's, lot # 100063 -all serial numbers. A response form is included. In addition, the Field Sales Representatives have been instructed to physically remove all lot 100063 of NeuroSensor Probes from inventory and provide replacement product.

Device

Device Recall Integra NeuroSensor
  • Model / Serial
    Lot 100063, all serial numbers
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Distribution: CA, GA, NM, TX, NE, WA, and NY.
  • Product Description
    INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences
  • Manufacturer
    Integra Neuro Sciences

Manufacturer

Integra Neuro Sciences
  • Manufacturer Address
    Integra Neuro Sciences, 5955 Pacific Center Blvd, San Diego CA 92121-4309
  • Source
    USFDA