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.

1–25 of 39

  • HighFDA (Devices)·Z-0220-2022·2021-11-24

    Cordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation

    Cordis Corporation is recalling the SMART FLEX Biliary Stent System (Lot 266586) due to potential distal tip dislodgement or separation. Affected units were distributed to select US states and Canada.

    Product
    SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0217-2022·2021-11-24

    SMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement

    Cordis Corporation is recalling 3 units of SMART FLEX 6x120 BIL biliary stents due to a potential for distal tip dislodgement or separation. No illnesses or injuries have been reported.

    Product
    SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0216-2022·2021-11-24

    FDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk

    Cordis Corporation is recalling 9 SMART FLEX 9x60 biliary stent units due to a potential for distal tip dislodgement or separation. The stents were distributed to patients in several U.S. states and Canada.

    Product
    SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0219-2022·2021-11-24

    SMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement

    Cordis Corporation is recalling SMART FLEX biliary stent systems due to a potential risk that the distal tip may dislodge or separate, which could compromise the stent's function.

    Product
    SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0221-2022·2021-11-24

    SMART FLEX Biliary Stent System Recalled for Potential Distal Tip Dislodgement

    Cordis Corporation is recalling 4 units of the SMART FLEX 10x100 BIL biliary stent system (Lot No. 271626) due to a potential for distal tip dislodgement or separation. The affected units were distributed in the US and Canada.

    Product
    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0218-2022·2021-11-24

    Cordis SMART FLEX Biliary Stent System recalled for potential tip separation

    Cordis is recalling the SMART FLEX 6x150 BIL biliary stent system due to potential separation of the distal tip. Approximately 26 units were distributed in the U.S. and Canada. Affected patients should contact their healthcare provider.

    Product
    SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2432-2021·2021-09-22

    Cordis SUPER TORQUE MB Angiographic Catheter Recalled for Device Entrapment Risk

    Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.

    Product
    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2428-2021·2021-09-22

    Angiographic Catheter Recall: Cordis SUPER TORQUE Entrapment and Dislodgement Risk

    Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or dislodgement.

    Product
    Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2429-2021·2021-09-22

    Cordis Angiographic Catheter Recall Due to Potential Marker Band Dislodgement

    Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing marker band movement or dislodgement.

    Product
    Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2430-2021·2021-09-22

    Cordis SUPER TORQUE Angiographic Catheter Recalled for Entrapment Risk

    Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.

    Product
    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2431-2021·2021-09-22

    Cordis Angiographic Catheter Recalled for Marker Band Dislodgement Risk

    Cordis is recalling angiographic catheters that may become entrapped between devices and vessel walls, risking marker band dislodgement during vascular procedures. Approximately 71,330 units were distributed worldwide.

    Product
    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2021·2021-08-18

    Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination

    Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.

    Product
    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2021·2021-07-21

    Catheter Sheath Introducer Recalled for Size Labeling Discrepancy

    Cordis Corporation is recalling 680 Avanti® Catheter Sheath Introducer units because the actual product dimensions are larger than the labeling indicates.

    Product
    Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2021·2021-03-24

    Cordis Precise Pro RX Carotid Stent Recall for Tip Separation

    Cordis is recalling Precise Pro RX Carotid Stent implant systems because the distal tip may separate from the lumen wire.

    Product
    PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1477-2020·2020-03-18

    Cordis Recalls POWERFLEX P3 Catheters Due to Potential Seal Voids

    Cordis is recalling one lot of POWERFLEX P3 PTA Dilation Catheters due to potential voids in the proximal seal area.

    Product
    Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0250-2020·2019-11-06

    Cordis MAXI LD PTA Dilatation Catheter Recalled for Expired Component

    Cordis Corporation is recalling 21 units of MAXI LD PTA Dilatation Catheters because they were manufactured using an expired inner body.

    Product
    Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-1198-2019·2019-04-24

    Cordis Guiding Catheters Recalled for Frayed Mounting Card Fragments

    Cordis Corporation is recalling Vista Brite Tip and Androit guiding catheters because frayed pieces of the mounting card were found inside the primary packaging.

    Product
    Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2019·2018-11-14

    Cordis POWERFLEX PRO PTA Dilatation Catheter Recalled for Burst Strength Failure

    Cordis Corporation is recalling 162 units of POWERFLEX PRO PTA Dilatation Catheters because they may not meet internal manufacturing burst strength specifications.

    Product
    Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The dev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2018·2018-01-17

    Cordis S.M.A.R.T. Flex Biliary Stent System Recalled for Cracked Luer Hubs

    Cordis Corporation is recalling 511 units of the S.M.A.R.T. Flex Biliary Stent System due to a potential for cracked luer hubs.

    Product
    Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1947-2016·2016-06-22

    Cordis PRECISE RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE RX Nitinol Stent Systems (Biliary) due to the inability to deploy the stent or partial deployment.

    Product
    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1946-2016·2016-06-22

    Cordis PRECISE PRO RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.

    Product
    Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2016·2016-03-23

    Cordis Avanti Catheter Sheath Introducer System Recalled for Incorrect Cannula Size

    Cordis Corporation is recalling 1,985 units of the Avanti Catheter Sheath Introducer System because the cannula is smaller than intended.

    Product
    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2015·2015-08-26

    Cordis RenLane Renal Denervation Catheter Recalled for Potential Tip Damage

    Cordis is recalling 98 RenLane Renal Denervation Catheters because the helical tip may be damaged if the arterial access device valve is not fully open.

    Product
    RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0998-2015·2015-01-28

    Cordis POWERFLEX PRO PTA Dilatation Catheter Recall for Unsterilized Unit

    Cordis Corporation is recalling one unsterilized unit of the POWERFLEX PRO PTA Dilatation Catheter from a demonstration lot left at a hospital.

    Product
    Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indic
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.