The Recall Desk

Manufacturer

Cordis Corporation

39 recalls in our database name Cordis Corporation as the manufacturing or recalling firm.

What the numbers show

Total
39
Critical
0
Severe
5
Most recent
2021-11-24

Of the 39 recalls from Cordis Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (13%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–39 of 39

  • HighFDA (Devices)·Z-2556-2014·2014-09-03

    Cordis EMPIRA NC RX PTCA Dilatation Catheter Recalled for Balloon Defect

    Cordis Corporation is recalling 250,000 EMPIRA NC RX PTCA Dilatation Catheters because the balloon cover may be difficult to remove, potentially causing the balloon to burst or the shaft to separate during use.

    Product
    Cordis EMPIRA NC RX PTCA Dilatation Catheter
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1784-2014·2014-06-18

    Cordis EMPIRA RX PTCA Dilatation Catheter Recalled for Potential Bursting

    Cordis Corporation is recalling 80 units of EMPIRA RX PTCA Dilatation Catheters because they may exhibit radial versus axial tears if they burst during inflation.

    Product
    Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0081-2014·2013-11-06

    Cordis Recalls Optease Vena Cava Filter Due to Printing Error

    Cordis is recalling 29,395 Optease Vena Cava Filters because a printing error on one unit caused it to be implanted upside down, requiring an additional procedure.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2014·2013-10-09

    Cordis ADROIT 6F Guiding Catheter Recalled for Labeling Error

    Cordis Corporation is recalling 1,238 units of ADROIT 6F Guiding Catheters due to a labeling error regarding the conversion of the inner diameter from inches to millimeters.

    Product
    Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1887-2013·2013-08-14

    Cordis OPTEASE Retrieval IVC Filter Recall for Labeling Clarification

    Cordis Corporation is recalling 33,000 units of the OPTEASE Retrieval IVC Filter to provide additional labeling that minimizes the likelihood of implanting the filter backwards.

    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. S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2013·2013-06-12

    Cordis Recalls FLEXSTENT Stent Systems Due to Pouch Integrity Issues

    Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2013·2013-06-12

    Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects

    Cordis is recalling 1,357 FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.

    Product
    FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2013·2013-06-12

    Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects

    Cordis Corporation is recalling 250 units of FLEXSTENT stent systems because holes or tears can form in the protective pouches.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1507-2013·2013-06-12

    Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects

    Cordis Corporation is recalling 23 units of FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.

    Product
    FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2013·2013-06-12

    Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects

    Cordis Corporation is recalling 310 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2013·2013-02-06

    Cordis ExoSeal Vascular Closure Device Recalled for Sterility Assurance Failure

    Cordis is recalling ExoSeal Vascular Closure Devices because the sterilization process did not meet required sterility assurance levels.

    Product
    Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2012·2012-10-03

    Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling

    Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because the products are incorrectly labeled.

    Product
    Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2441-2012·2012-10-03

    Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling

    Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because they are incorrectly labeled.

    Product
    Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 500
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Cordis Corporation

subsidiary of Johnson & Johnson that develops and manufactures medical devices

Country
United States
Founded
1957

Official website

Source: Wikidata (Q4698292), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.