Recall of MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Oscor, 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
    75785
  • Event Risk Class
    Class 2
  • Event Number
    Z-0811-2017
  • Event Initiated Date
    2016-10-05
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Introducer, catheter - Product Code DYB
  • Reason
    Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
  • Action
    Oscor sent two(2) Product Recall notifications: -HOSPITALS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Review, complete, sign and return the enclosed Acknowledgement Form attached in the letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email RGA@Oscor.com Hours of operations: Monday to Friday from 8:30AM to 5:30PM Eastern Time. - DISTRIBUTORS: Immediately check your inventory to confirm that you do or do not have units from these lot(s) in your possession. Identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. Check all storage and usage. Please pull a list of the hospitals (end user) impacted by the affected lots and retrieve inventory for replacement, if available. Review, complete, sign and return the enclosed Acknowledgement Form (Exhibit A) attached in this letter, directly to Oscor Inc. at the fax number or e-mail on the form, for immediate replacement (as applicable). Who to call: Please call Oscor Inc. Customer Service Department at 727-937-2511 or email RGA@Oscor.com Hours of operation: Monday to Friday from 8:30AM to 5:30PM Eastern Standard Time.

Device

  • Model / Serial
    Lot #'s: C1-08604 Exp. February 20, 2017, C1-08938Exp. May 19, 2017, C1-08986 Exp. June 1, 2017, OR-04488 Exp. June 30, 2017, C1-09756 Exp. February 18, 2018, C1-09757 Exp. February 18, 2018, OR-04633 Exp. March 10, 2018, C1-10118 Exp. April 17, 2018, C1-10119 Exp. April 17, 2018, C1-10147 Exp. April 23, 2018, and C1-12525 Exp. May 17, 2019
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
  • Product Description
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 || Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Oscor, Inc., 3816 Desoto Blvd, Palm Harbor FL 34683-1618
  • Manufacturer Parent Company (2017)
  • Source
    USFDA