RecallRadar

FDA Device recall Z-1887-2013

Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat

On 2013-08-14 the FDA classified a Class I recall of Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat by Cordis, citing correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1887-2013
ClassificationClass I
Statusterminated
Initiated2013-03-29
Published2013-08-14
Last updated2026-09-13 11:53 UTC
CompanyCordis
DistributionUS

Product

Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB 10247519.2/***LB466F220AO.5***omoraoro/2012.050794***Do 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.

Reason

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

Identifiers

code_infoModel Numbers 466F220A and 466F220B.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1887-2013%22

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