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.
Recall
- Recall Number
- Z-0081-2014
- Event Number
- 66483
- Firm
- Cordis Corporation
- FEI Number
- 1016427
- Product Code
- DTK
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- September 27, 2013
- Posted
- October 25, 2013
- Terminated
- September 23, 2014
- Address
- 14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802
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.
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.
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.
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.
29,395 units