Events

Recall of Boston Scientific CAPIO™ Monodek® Violet Monofilament Polydioxanone Sutures, Absorbable Surgical Sutures

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Teleflex 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
    16399
  • Event Initiated Date
    2014-03-21
  • 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: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • Reason
    Manufacturer has notified that certain lots of their products did not meet minimum needle attachment strength, knot tensile strength, minimum diameter, or minimum resorption strength requirements. this may result in suture breakage, delay in procedure, wound dehiscence, or the need for additional surgical intervention.
  • Action
    Product to be returned to supplier

Device

Boston Scientific CAPIO™ Monodek® Violet Monofilament Polydioxanone Sutures, Absorbable Surgical ...
  • Model / Serial
    Model: 833-137, Affected: 02A0901938, 02B0901537 02C1102979, 02C1102983 02C1302078, 02D1300294 02D1301164, 02D1302468 02H1001025, 02H1001026 02H1001027, 02H1103434 02H1200349, 02K1201354
  • Manufacturer
    Teleflex Medical Inc

Manufacturer

Teleflex Medical Inc