Events

Recall of MICRUS MICROCOIL SYSTEM - MODIFIED CERECYTE MICROCOIL - CSP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MICRUS ENDOVASCULAR CORPORATION.

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
    114431
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Dimensional issues associated with the connector hub that is used to attach the device positioning unit to the detachment control cable. loss of electrical conductivity can result in failure to detach a coil for deployment inside an aneurysm.

Device

MICRUS MICROCOIL SYSTEM - MODIFIED CERECYTE MICROCOIL - CSP
  • Model / Serial
    Model Catalog: CSP100400-30 (Lot serial: g11062); Model Catalog: SRC140922-20 (Lot serial: >10 numbers contact mfg); Model Catalog: SRC140717-20 (Lot serial: >10 numbers contact mfg); Model Catalog: SRC140615-20 (Lot serial: >10 numbers contact mfg); Model Catalog: SRC140303-20 (Lot serial: >10 numbers contact mfg); Model Catalog: SRC140408-20 (Lot serial: >10 numbers contact mfg); Model Catalog: SRC140306-20 (Lot serial: >10 numbers contact mfg); Model Catalog: CDF100410-30 (Lot serial: g10987); Model Catalog: CSP100300-30 (Lot serial: g11062); Model Catalog: CRC140306-30 (Lot serial: g10996); Model Catalog: CSP100300-30 (Lot serial: g11180); Model Catalog: CSP100400-30 (Lot serial: g11180); Model Catalog: CRC140306-30 (Lot serial: g11310); Model Catalog: DFS100156-20 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: DFS100154-20 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: DFS100152-20 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: DFS100254-20 (Lot serial: >10 NUMBERS CONTACT MFG); Mod
  • Product Description
    Micrus Endovascular Microcoil System-Modified Cerecyte Microcoil - CSP
  • Manufacturer
    MICRUS ENDOVASCULAR CORPORATION

Manufacturer

MICRUS ENDOVASCULAR CORPORATION