Events

Recall of MiniArc Pro Single incision Sling System

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

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
    72552
  • Event Risk Class
    Class 2
  • Event Number
    Z-0279-2016
  • Event Initiated Date
    2015-10-26
  • Event Date Posted
    2015-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141509
  • 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
    mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling - Product Code PAH
  • Reason
    The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. the identification labels inside the box are placed on medical records and other documents associated with the procedure. use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
  • Action
    Consignees were hand delivered by sales representatives a Astora Women's Health "Urgent Recall Notice". The letter was addressed to Physician, Health Care Professional, Nurse & Risk Manager. The letter described the problem and the product involved in the recall. Consignees were advised to check their inventory and return all affected product, notify those that might be affected and to complete and return the Acknowledgement Form. For questions contact ASTORA Women's Health Customer Service at 1-844-879-0787.

Device

MiniArc Pro Single incision Sling System
  • Model / Serial
    Lot number 936405. Serial numbers 936405001 through 936405056
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
  • Product Description
    MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
  • Manufacturer
    Astora

Manufacturer

Astora
  • Manufacturer Address
    Astora, 13200 Pioneer Trl, Eden Prairie MN 55347-4119
  • Source
    USFDA