Events

Recall of Cordis OPTEASE Vena Cava Filter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis 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
    66483
  • Event Risk Class
    Class 2
  • Event Number
    Z-0081-2014
  • Event Date Posted
    2013-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122464
  • 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
    Filter, intravascular, cardiovascular - Product Code DTK
  • Reason
    Cordis identified a printing error on one unit of the optease vena cava filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. the error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter.
  • Action
    Cordis sent an Urgent Medical Device Recall letter dated October 8, 2013, to all affected customers. The letter identified the product (Cordis OPTEASE¿ Vena Cava Filter Catalog Numbers 466F220A and 466F220B), the problem, and the action to be taken by the customer. Customers were instructed to: 1) Read this Urgent Medical Device Recall letter. 2) Immediately identify and set aside all product listed below in a manner that ensures the affected product will not be used. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. 4) Return any affected product with reference to the RA# on the form. Contact Customer Service (see Available Assistance section) if assistance is needed for return of the affected product. Credit will be provided or consignment levels reduced. 5) Share this letter with others in your facility that need to be made aware of this recall. 6) Contact any other facility to arrange the return of OPTEASE¿ if any product listed below has been forwarded to them. 7) Maintain awareness of this notice until all affected product has been returned to Cordis. 8) Keep a copy of this notice with the affected product. Please contact the special Customer Service number (800) 551-7683, Monday through Friday from 8:30 AM to 6:30 PM ET. o Return instructions are provided on the Acknowledgment Form. Questions related to the Acknowledgement Form " Please contact Cordis QA at (786) 313-8730. For questions regarding this recall call 1-800-551-7683.

Device

Cordis OPTEASE Vena Cava Filter
  • Model / Serial
    15277209 15414364 15560257 15752429 15287302 15550200 15282988 15421769 15565526 15753478 15291145 15566741 15287301 15424883 15568635 15755303 15307389 15570058 15290545 15430268 15572971 15761315 15311637 15582190 15291146 15435116 15579473 15767566 15325508 15593534 15296278 15437943 15581926 15777997 15343213 15612686 15300299 15444314 15585734 15781096 15355694 15627268 15300995 15448466 15591471 15789723 15369568 15638012 15307390 15450171 15593533 15793939 15381573 15652041 15307999 15454044 15598216 15799364 15402503 15670744 15312441 15456163 15605008 15802178 15406808 15686286 15317387 15460104 15606053 15809353 15430934 15699350 15320551 15466748 15610330 15812239 15435039 15737306 15325507 15471008 15614689 15816462 15444313 15762046 15330287 15473247 15627966 15822489 15462543 15768649 15335203 15478342 15632159 15830469 15466749 15793940 15340786 15480569 15632931 15836564 15473249 15798681 15344590 15487383 15637332 15839559 15481997 15814435 15350806 15490348 15643482 15843764 15495653 15820539 15353473 15495652 15647053 15848940 15506862 15845139 15358769 15501261 15652040 15855704 15525423 15854729 15366482 15501864 15656567 15857848 15543607 15860770 15370260 15505204 15659250 15863068 15375958 15513357 15667702 15870135 15380088 15518418 15670742 15875172 15385970 15522427 15675940 15878645 15386960 15526913 15683409 15884283 15386963 15529312 15690240 15896484 15389049 15530028 15694650 15918862 15391340 15535323 15698900 15925083 15396804 15538438 15704985 15932575 15400773 15544128 15707198 15932586 15406817 15546019 15736818 15950327 15408669 15551821 15742478 15961621 15409489 15556617 15747949
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) including Hawaii and Puerto Rico and states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Canada and Panama.
  • Product Description
    Cordis OPTEASE Vena Cava Filter || Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA