Arrow International Inc

FDA Regulatory Profile

Summary

Total Recalls
478 (57 Class I)
510(k) Clearances
22
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3299-2024Class IIArrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire July 26, 2024
Z-1880-2024Class IArrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-UApril 29, 2024
Z-1879-2024Class IArrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REFApril 29, 2024
Z-1878-2024Class IArrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; April 29, 2024
Z-1267-2024Class IARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-042February 12, 2024
Z-2591-2023Class IIArrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VAugust 10, 2023
Z-0001-2024Class IArrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPSAugust 10, 2023
Z-2590-2023Class IIArrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascularAugust 10, 2023
Z-0003-2024Class IArrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravaAugust 10, 2023
Z-0002-2024Class IArrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCAugust 10, 2023
Z-0004-2024Class IArrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPAugust 10, 2023
Z-1826-2023Class IARROW Endurance Extended Dwell Peripheral Catheter SystemMay 19, 2023
Z-0351-2023Class IArrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; October 27, 2022
Z-0352-2023Class IPressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-4October 27, 2022
Z-0439-2023Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cOctober 17, 2022
Z-0441-2023Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), October 17, 2022
Z-0443-2023Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), October 17, 2022
Z-0427-2023Class IArrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cOctober 17, 2022
Z-0438-2023Class IArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), October 17, 2022
Z-0450-2023Class IArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), October 17, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K250542AC3™ Range™ Intra-Aortic Balloon PumpMarch 26, 2025
K232343AC3™ Series IABPAugust 30, 2023
K222341Arrow 0.2 Micron Flat Filter, GVSFebruary 13, 2023
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPMay 27, 2020
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitApril 9, 2020
K190101UltraFlex IABJune 28, 2019
K190117Fiberoptix IABJune 13, 2019
K162820AC3 Series IABP SystemMarch 31, 2017
K141051VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROJuly 7, 2014
K130192NEXTSTEP RETROGRADEMay 10, 2013
K130876CG+ ARROW PICC POWERED BY ARROW VPS STYLETApril 26, 2013
K122690ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLEDecember 21, 2012
K122027ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETERAugust 28, 2012
K113277ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSJune 21, 2012
K080604PRESSURE INJFECTABLE PICCJune 27, 2008
K073451PRESSURE INJECTABLE PICCJanuary 15, 2008
K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERAugust 30, 2007
K061289ARROW PRESSURE INJECTABLE PICCAugust 24, 2006
K041740SILICONE COATED GUIDEWIREOctober 15, 2004
K040666STEP-TIP CHRONIC HEMODIALYSIS CATHETERMay 14, 2004