Device recall: Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) FilterREF Cat. No.466F220A and 466F220B***Vena Cava Filter and…

Class I FDA enforcement event 65482. Recall start date: 29 Mar 2013. Status in the FDA record: Terminated. Termination date: 27 Oct 2014.

Reason for recall, in the words of FDA

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

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Cordis Corporation started this device recall on 29 Mar 2013. The firm address in the FDA record is in Miami Lakes, FL. FDA put the recall in Class I. FDA event 65482 has 1 product record. The first FDA enforcement report date is 14 Aug 2013. The record gives the status Terminated, with the termination date 27 Oct 2014.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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,…

Recalling firm

Cordis Corporation, Miami Lakes, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 65482: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1887-2013	Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter*REF 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…	33,000 units	Class I	Terminated	14 Aug 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class I: 6%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 23

Other events of the firm

Other FDA enforcement events of Cordis Corporation
Initiated	Product (first record)	Type	Class	Records
1 Oct 2021	SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T. Flex Biliary Stent System is indicated for use in the palliation of malignant s	Device	Class II	6
21 Jul 2021	Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB	Device	Class I	5
19 Jul 2021	Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X	Device	Class II	1
9 Jun 2021	Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring per	Device	Class II	1
11 Feb 2021	PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC064	Device	Class I	1
8 Jan 2020	Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S	Device	Class II	1
4 Oct 2019	Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.	Device	Class II	1
7 Feb 2019	Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravasc	Device	Class III	1
5 Sep 2018	Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-fem	Device	Class II	1
15 Nov 2017	Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant stricture	Device	Class II	1

Cordis Corporation: all 23 events

Official channels

FDA enforcement report Z-1887-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 65482. https://recallregister.com/fda/i/65482/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: 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,…
What quantity of product is in FDA event 65482?: The FDA record gives this quantity: 33,000 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 6% of the 1,236 device events that started in 2013 are in Class I.