Events

Recall of ECLIPSE PMR SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDIOGENESIS A CRYOLIFE INC. COMPANY.

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
    23509
  • Event Risk Class
    II
  • Event Initiated Date
    2001-04-12
  • 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
    Possible delamination of the inner lining of the aligning catheter when inserting a nd retracting the laser catheter.

Device

ECLIPSE PMR SYSTEM
  • Model / Serial
    Model Catalog: BM000809 (Lot serial: DEV. LIC. 20373); Model Catalog: BM000804 (Lot serial: DEV. LIC. 20373); Model Catalog: BM000860 (Lot serial: VARIOUS LOT NO'S); Model Catalog: BM000810 (Lot serial: DEV. LIC. 20373); Model Catalog: BM000854 (Lot serial: DEV. LIC. 20373); Model Catalog: BM000859 (Lot serial: VARIOUS LOT NO'S); Model Catalog: BM000860 (Lot serial: DEV. LIC. 20373); Model Catalog: BM000804 (Lot serial: VARIOUS LOT NO'S); Model Catalog: BM000809 (Lot serial: VARIOUS LOT NO'S); Model Catalog: BM000810 (Lot serial: VARIOUS LOT NO'S); Model Catalog: BM000854 (Lot serial: VARIOUS LOT NO'S); Model Catalog: BM000859 (Lot serial: DEV. LIC. 20373)
  • Product Description
    AXCIS ALIGNING CATHETERS
  • Manufacturer
    CARDIOGENESIS A CRYOLIFE INC. COMPANY

Manufacturer

CARDIOGENESIS A CRYOLIFE INC. COMPANY
  • Manufacturer Address
    KENNESAW
  • Source
    HC