Events

Recall of FemoSeal

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by St Jude Medical 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
    21834
  • Event Initiated Date
    2017-08-21
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Reason
    The manufacturers investigation has identified that the internal suture becomes entrapped as a result of operator misassembly during device manufacture and that this issue then only becoming visible midway through device deployment. internal controls have been established in manufacturing to eliminate the potential for this defect to recur.
  • Action
    Product to be returned to supplier

Device

FemoSeal
  • Model / Serial
    Model: , Affected: All non-expired product Manufactured August 2016 - July 2017
  • Manufacturer
    St Jude Medical Inc

Manufacturer

St Jude Medical Inc