Events

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-0812-2017
  • Event Initiated Date
    2016-10-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151334
  • 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

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH
  • Model / Serial
    Lot #'s: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017, C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018, C1-09862 Exp. March 5, 2018, C1-09903 Exp. March 15, 2018, C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018, C1-10185 Exp. April 27, 2018, C1-10214 Exp. April 29, 2018, C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018, C1-11485 Exp. September 22, 2018, C1-11623 Exp. September 29, 2018, C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp. December 22, 2018, and OR-04758 Exp. December 22, 2018
  • Product Classification
    Cardiovascular Devices
  • 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 C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 || Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
  • Manufacturer
    Oscor, Inc.

Manufacturer

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