Recall Z-0081-2014— Cordis Corporation

Name: FDA recall Z-0081-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-27

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2013-09-27, terminated 2014-09-23. It names one FDA 510(k) clearance: K091077. Product: 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.. 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..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-09-27
Terminated: 2014-09-23
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K091077 — OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETERCordis Corp., A Johnson & Johnson Co.·cleared 2010-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.