Terminated

Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) FilterREF Cat. No.466F220A and 466F220BVena Cava Filter and Introduction Kit(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)Cordisa Johnson and Johnson CompanyENDOVASCULAR Label No. SB 10247519.2/LB466F220AO.5omoraoro/2012.050794Do not resterilize. Product Usage: The OPTEASE Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in several situations: Pulmonary thromboembolism when anticoagulants are contraindicated; Failure of anticoagulant therapy for thromboembolic disease; Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.

FDA Recall Z-1887-2013 · Posted 2013-08-07

Recalling FirmCordis Corporation

Recall StatusTerminated

Product CodeDTK

Date Initiated2013-03-29

Date Terminated2014-10-27

Product Quantity33,000 units

Reason for Recall

Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.

Firm Action

Cordis Corporation sent an "URGENT Medical Device Correction" notification to their consignees in the US by letter dated April 3, 2013 and an e-mail was sent to the Canadian consignees. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to read the description and recommendations sections carefully, then sign and return the enclosed Acknowledgement Form directly to Cordis to their fax number(908) 429-8287 or Scan and e-mail to [email protected]. The letter states to pass on the notice to anyone in the consignees' facilities that need to be informed. Additionally, the notification request consignees to maintain awareness of this notification until the information has been incorporated in the Cordis OPTEASE Vena Cava Filter labeling. For questions related to the issue contact Cordis Endovascular Medical Information Line 877-338-4235.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution - USA Nationwide in the states of 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, WY, including Hawaii and Puerto Rico and the countries of Canada & Panama

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091077OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETERCordis Corp., A Johnson & Johnson Co. · 2010-02-04 K034050CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220FCordis Corporation · 2004-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.