Events

Recall of RELIEVA FLEX Sinus Guide Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Acclarent, 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
    71232
  • Event Risk Class
    Class 3
  • Event Number
    Z-1740-2015
  • Event Initiated Date
    2015-04-28
  • Event Date Posted
    2015-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136915
  • 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
    Cannula, sinus - Product Code KAM
  • Reason
    Acclarent determined that one single relieva flex sinus guide catheter was distributed past it's expiry date.
  • Action
    Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions. Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398.

Device

RELIEVA FLEX Sinus Guide Catheter
  • Model / Serial
    Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US in the state of Texas
  • Product Description
    RELIEVA FLEX Sinus Guide Catheter F-70. || Catalog number GC070RF. || Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. || .
  • Manufacturer
    Acclarent, Inc.

Manufacturer

Acclarent, Inc.
  • Manufacturer Address
    Acclarent, Inc., 1525B Obrien Dr, Menlo Park CA 94025-1463
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA