The Recall Desk

Manufacturer

ARROW INTERNATIONAL Inc.

478 recalls in our database name ARROW INTERNATIONAL Inc. as the manufacturing or recalling firm.

What the numbers show

Total
478
Critical
1
Severe
146
Most recent
2024-10-02

Of the 478 recalls from ARROW INTERNATIONAL Inc. we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 146 (31%) 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.

26–50 of 478

  • SevereFDA (Devices)·Z-0352-2023·2022-12-21

    Central Venous Catheter Kits Recalled for Potential Connector Housing Failure

    ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.

    Product
    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0445-2023·2022-12-21

    Arrow AutoCAT 2 Cardiac Pump Recalled for Potential Battery Runtime Issue

    Arrow International is recalling Arrow AutoCAT 2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0442-2023·2022-12-21

    Arrow AC3 Optimus IABP Devices Recalled for Short Battery Run-Time Issue

    Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0446-2023·2022-12-21

    Arrow AutoCAT 2 Cardiac Pump Recalled for Battery Runtime Issues

    Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0451-2023·2022-12-21

    FDA Recalls Arrow AutoCAT2WAVE IABP for Short Battery Runtime

    The Arrow AutoCAT2WAVE intra-aortic balloon pump is being recalled worldwide due to a potential issue with short battery run-times. Healthcare facilities should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0454-2023·2022-12-21

    Intra-Aortic Balloon Pump Battery Run-Time Issue Recall

    Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0452-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues

    Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0449-2023·2022-12-21

    Intra-Aortic Balloon Pump with Potential Short Battery Run-Times

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0437-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous cardiac support.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0351-2023·2022-12-21

    Arrow MAC Two-Lumen Central Venous Access Kit connector housing defect

    ARROW INTERNATIONAL is recalling Arrow MAC Two-Lumen Central Venous Access Kits due to potential inadequate connection between the top and bottom housings of included Micro Clave Clear Connectors.

    Product
    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0455-2023·2022-12-21

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0426-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times

    Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0456-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0432-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Recall

    The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0427-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump: Short Battery Run-Time Issue

    Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0433-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Battery Run-Time Issue

    Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0453-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Short Battery Runtime

    The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0444-2023·2022-12-21

    Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall

    Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0430-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump short battery run-time issue

    Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0441-2023·2022-12-21

    Arrow AC3 Optimus Intra-Aortic Balloon Pumps recalled for short battery runtime

    Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0102-2023·2022-10-26

    ARROW Midline Catheter Kit Mislabeled with Wrong Device Type

    ARROW INTERNATIONAL Inc. is recalling an ARROW Pressure Injectable Arrowgard Blue Advance Midline Catheter Kit due to mislabeling. The package labels incorrectly specify a double-lumen 5.5 French catheter, but the kit contains a single-lumen 4.5 French catheter.

    Product
    ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2022·2022-07-06

    Central venous catheter recalled for incorrect gravity flow rates

    Arrow International is recalling the Arrow Three-Lumen CVC due to incorrect gravity flow rates on the product lidstock. The defect may affect fluid and medication delivery through the catheter.

    Product
    Arrow Three-Lumen CVC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0234-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk

    Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0232-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall

    Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0231-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall

    The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native…
    Category
    Medical Device
    Distribution
    Distributed nationwide