Events

Recall of Synthesis

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

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
    69879
  • Event Risk Class
    Class 2
  • Event Number
    Z-0877-2015
  • Event Initiated Date
    2014-10-06
  • Event Date Posted
    2014-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131893
  • 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
    Syringe, balloon inflation - Product Code MAV
  • Reason
    Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure.
  • Action
    Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.

Device

Synthesis
  • Model / Serial
    Batch numbers: 4041354/4062650/4072586
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AZ and CO.
  • Product Description
    Synthes Inflation System (03.804.4135) || Product Usage: || Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
  • Manufacturer
    PEROUSE MEDICAL

Manufacturer

PEROUSE MEDICAL
  • Manufacturer Address
    PEROUSE MEDICAL, ROUTE DU MANOIR, Ivry Le Temple France
  • Manufacturer Parent Company (2017)
    Perouse Medical
  • Source
    USFDA