The Recall Desk

Manufacturer

Arrow International, Inc., Division of Teleflex Medical Inc.

9 recalls in our database name Arrow International, Inc., Division of Teleflex Medical Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
4
Severe
1
Most recent
2016-03-16

Of the 9 recalls from Arrow International, Inc., Division of Teleflex Medical Inc. we have scored against our rubric, 4 (44%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (11%) 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.

1–9 of 9

  • CriticalFDA (Devices)·Z-1063-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling Percutaneous Insertion Trays because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1058-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1059-2016·2016-03-16

    Arrow UltraFlex IAB Recall: Sheath Separation Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1061-2016·2016-03-16

    Arrow RediGuard IAB Recall Due to Sheath Separation Risk

    Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1062-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling specific Percutaneous Insertion Trays because the sheath body may separate from the hub, posing a risk of bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2016·2016-03-16

    Arrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation

    Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, creating a risk of bleeding.

    Product
    FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2016·2016-03-16

    Arrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases wor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2016·2016-03-16

    Arrow FiberOptix Ultra 8 IAB recalled for potential sheath separation

    Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, posing a risk of bleeding.

    Product
    FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decr
    Category
    Medical Device
    Distribution
    Distributed nationwide