The Recall Desk

Manufacturer

Cordis US Corp

22 recalls in our database name Cordis US Corp as the manufacturing or recalling firm.

What the numbers show

Total
22
Critical
1
Severe
13
Most recent
2025-04-09

Of the 22 recalls from Cordis US Corp we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (59%) 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.

1–22 of 22

  • HighFDA (Devices)·Z-1510-2025·2025-04-09

    Cordis Smart Control Vascular Stent Size Mismatch Recalled

    Cordis recalled 20 units of its Smart Control Vascular Stent System ILIAC due to a labeling mix-up where the external label does not match the actual stent size. Wrong-sized stents could cause serious vessel complications if implanted.

    Product
    Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1511-2025·2025-04-09

    Cordis Vascular Stent System Recalled Due to Incorrect Product Size

    Cordis US Corp recalls Smart Control Vascular Stent System ILIAC devices due to product mix-up where some units are labeled 9mm X 60mm but contain different stent sizes. Patients should consult their healthcare provider immediately.

    Product
    Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1330-2025·2025-03-19

    Vista Brite Tip Guiding Catheter Manufactured at Incorrect Length

    Cordis US Corp is recalling Vista Brite Tip guiding catheters manufactured at incorrect length. The defect may affect proper catheter placement during interventional or diagnostic vascular procedures.

    Product
    Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0675-2024·2024-01-17

    Cordis MYNXGRIP Vascular Closure Device Carton Labeling Error

    Cordis recalled 70 units of MYNXGRIP vascular closure devices due to carton label errors affecting two lots. Carton boxes were labeled incorrectly, though individual device labels are correct.

    Product
    MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0674-2024·2024-01-17

    Cordis MYNXGRIP 5F Vascular Closure Device Carton Labeling Error

    Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.

    Product
    MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0286-2024·2023-11-15

    Cordis Cardiac Catheter Sets Distributed Non-Sterile, Labeled Sterile

    Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.

    Product
    Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1496-2023·2023-05-17

    Cordis Angioguard Emboli Capture Guidewire System Faces Separation Hazard

    Cordis's Angioguard RX/XP Emboli Capture Guidewire System is recalled due to potential separation of the delivery system and capture sheath, which could cause procedural delays, unplanned intervention, or stroke during use.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1493-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System recalled due to potential device separation

    Cordis US Corp's ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled by the FDA (Class I) because the delivery system and capture sheath may separate during medical procedures, potentially requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1492-2023·2023-05-17

    ANGIOGUARD Emboli Capture Guidewire System Recalled Due to Device Separation

    The FDA has recalled the ANGIOGUARD RX/XP Emboli Capture Guidewire System because the delivery system and capture sheath could separate during use, potentially causing stroke or requiring emergency surgery.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1483-2023·2023-05-17

    ANGIOGUARD RX / XP Emboli Capture Guidewire System separation during procedures

    The ANGIOGUARD RX / XP emboli capture guidewire system may separate from its delivery sheath during medical procedures, potentially leading to stroke or complications requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1489-2023·2023-05-17

    Emboli Capture Guidewire System recalls risk of device separation during procedures

    Cordis is recalling an emboli capture guidewire system due to potential separation of components during medical procedures. The separation could cause procedural delays, unplanned interventions, or stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1488-2023·2023-05-17

    FDA Class I Guidewire System Recalled for Device Separation Risk

    Cordis US Corp is recalling the ANGIOGUARD RX / XP Emboli Capture Guidewire System because the device may separate during procedures, risking stroke or requiring emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2023·2023-05-17

    Emboli Capture Guidewire System Recalled Due to Potential Component Separation

    Cordis US Corp recalls 54 units of the ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of device components. This could delay procedures or result in unplanned intervention, including possible stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1491-2023·2023-05-17

    Emboli Capture Guidewire System recalled due to potential device separation

    Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (1,087 units worldwide) due to potential separation of the delivery system and capture sheath, which could lead to stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2023·2023-05-17

    ANGIOGUARD RX/XP Emboli Capture Guidewire System May Separate During Procedures

    ANGIOGUARD RX/XP emboli capture guidewire systems may separate from their delivery sheaths during interventional procedures, potentially causing stroke. Cordis is recalling 56 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1487-2023·2023-05-17

    Emboli Capture Guidewire System Separation Hazard Prompts FDA Recall

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate from its delivery sheath during medical procedures, potentially causing stroke or requiring emergency surgery. Cordis US Corp is recalling 146 units worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1494-2023·2023-05-17

    Emboli Capture Guidewire System recalled for component separation risk

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled because the delivery system and capture sheath may separate during procedures, potentially causing stroke or requiring emergency surgical intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1495-2023·2023-05-17

    Emboli Capture Guidewire System Separation Risk Recalls ANGIOGUARD RX/XP

    Cordis US Corp is recalling ANGIOGUARD RX/XP Emboli Capture Guidewire Systems worldwide due to potential separation of the delivery system and capture sheath during procedures, which could cause stroke or require emergency intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1485-2023·2023-05-17

    ANGIOGUARD RX/XP Guidewire System May Separate During Medical Procedures

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System may separate during medical procedures, potentially delaying treatment or requiring unplanned intervention. The recall affects 471 units distributed worldwide.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1484-2023·2023-05-17

    ANGIOGUARD RX/XP Emboli Capture Guidewire System Separation Risk

    Cordis has recalled 684 units of ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of the delivery system and capture sheath during use, which could cause stroke or require unplanned surgical intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0720-2023·2022-12-21

    Cordis Angiographic Catheter Extensions Recalled for Male Connector Separation Risk

    Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.

    Product
    Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2022·2022-07-20

    PALMAZ GENESIS Transhepatic Biliary Stent Risk of Dislodgement

    Cordis is recalling 1,089 units of PALMAZ GENESIS Transhepatic Biliary Stents due to potential stent dislodgement in two specific device sizes. Affected patients should contact their healthcare provider.

    Product
    PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
    Category
    Medical Device
    Distribution
    Distributed nationwide