Events

Recall of DESTINATION CAROTID GUIDING SHEATH

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO MEDICAL 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
    144345
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-17
  • 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
    Certain pinnacle destination guiding sheaths containing an expiration date on or before august 31 2018 may fail to meet product specifications for insertion force of 40 grams (1.4 ounces). if a guiding sheath does not have sufficient lubricity there may be increased resistance noted during the insertion of the device into the patient especially if the patient has scar tissue or difficult anatomy.

Device

DESTINATION CAROTID GUIDING SHEATH
  • Model / Serial
    Model Catalog: RSC03 (Lot serial: >10 contact mfg); Model Catalog: RSC02 (Lot serial: >10 contact mfg); Model Catalog: RSC01 (Lot serial: >10 contact mfg); Model Catalog: 54-89006 (Lot serial: >10 contact mfg); Model Catalog: 54-89001 (Lot serial: >10 contact mfg); Model Catalog: 54-86506 (Lot serial: >10 contact mfg); Model Catalog: 54-86501 (Lot serial: >10 contact mfg); Model Catalog: 54-84501 (Lot serial: >10 contact mfg); Model Catalog: 54-74501 (Lot serial: >10 contact mfg); Model Catalog: 54-64506 (Lot serial: >10 contact mfg); Model Catalog: 54-54502 (Lot serial: >10 contact mfg); Model Catalog: RSP03 (Lot serial: >10 contact mfg); Model Catalog: RSP02 (Lot serial: >10 contact mfg); Model Catalog: RSP01 (Lot serial: >10 contact mfg); Model Catalog: 54-54501 (Lot serial: >10 contact mfg); Model Catalog: RSR17 (Lot serial: >10 contact mfg); Model Catalog: RSR16 (Lot serial: >10 contact mfg); Model Catalog: RSR15 (Lot serial: >10 contact mfg); Model Catalog: RSR14 (Lot serial: >10 contact mfg); Model Ca
  • Product Description
    Destination Carotid Guiding Sheath;Destination Peripheral Guiding Sheath;Destination Renal Guiding Sheath
  • Manufacturer
    TERUMO MEDICAL CORPORATION

Manufacturer

TERUMO MEDICAL CORPORATION
  • Manufacturer Address
    ELKTON
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    HC