Events

Recall of Sorin/Perceval Sutureless Aortic Valve

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Sorin Group Italia Srl.

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
    23303
  • Event Initiated Date
    2018-07-06
  • 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: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Reason
    The manufacturer has recently become aware, through its post-market surveillance processes, of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to "stent folding".
  • Action
    Manufacturer to issue advice regarding use

Device

Sorin/Perceval Sutureless Aortic Valve
  • Model / Serial
    Model: Perceval Sutureless Aortic Heart Valve size S, Perceval Sutureless Aortic Heart Valve size M, Perceval Sutureless Aortic Heart Valve size L, Perceval Sutureless Aortic Heart Valve size XL, Affected:
  • Manufacturer
    Sorin Group Italia Srl

Manufacturer

Sorin Group Italia Srl