ClearanceBrief
Recall Z-0081-2014 ยท DTK Filter, Intravascular, Cardiovascular

Cordis Corporation

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

DateOct 25, 2013 (initiated Sep 27, 2013)
StatusTerminated
ReasonCordis 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.
Root causeError in labeling
ActionCordis 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)
Quantity29,395 units
DistributionWorldwide 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 countri
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K091077OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
Cordis Corp., A Johnson & Johnson Co., Feb 4, 2010