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All Recalls

Every Arrow International Inc Recall

Sorted by most recent. Click any recall for full details.

321 recalls
High RiskFDA
Arrow International Inc.
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF AS...
Surgical Devices·14,845 affected·Jul 26, 2024
CriticalFDA
Arrow International Inc.
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Surgical Devices·7,939 affected·Apr 29, 2024
CriticalFDA
Arrow International Inc.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Surgical Devices·44,807 affected·Apr 29, 2024
CriticalFDA
Arrow International Inc.
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Surgical Devices·3,138 affected·Apr 29, 2024
High RiskFDA
Arrow International Inc.
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Surgical Devices·190 affected·Aug 10, 2023
CriticalFDA
Arrow International Inc.
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TT...
Surgical Devices·172 affected·Aug 10, 2023
High RiskFDA
Arrow International Inc.
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted...
Medical Implants·177 affected·Aug 10, 2023
CriticalFDA
Arrow International Inc.
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therape...
Surgical Devices·180 affected·Aug 10, 2023
CriticalFDA
Arrow International Inc.
ARROW Endurance Extended Dwell Peripheral Catheter System
Surgical Devices·262,016 affected·May 19, 2023
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Cardiac Devices·1 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Cardiac Devices·1 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Cardiac Devices·81 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Cardiac Devices·12 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
Cardiac Devices·15 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Cardiac Devices·4 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Cardiac Devices·1,394 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Cardiac Devices·4 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
Cardiac Devices·48 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
Cardiac Devices·112 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Cardiac Devices·0 affected·Oct 17, 2022
CriticalFDA
Arrow International Inc.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
Cardiac Devices·39 affected·Oct 17, 2022
High RiskFDA
Arrow International Inc.
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For periphe...
Medical Devices·18 affected·Sep 14, 2022
CriticalFDA
Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous ...
Surgical Devices·1,167 affected·Sep 20, 2021
CriticalFDA
Arrow International Inc
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous...
Surgical Devices·1,918 affected·Sep 20, 2021
High RiskFDA
Arrow International Inc
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in ...
Cardiac Devices·48 affected·May 19, 2021
High RiskFDA
Arrow International Inc
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended ...
Cardiac Devices·5 affected·May 19, 2021
High RiskFDA
Arrow International Inc
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophys...
Cardiac Devices·4 affected·May 19, 2021
High RiskFDA
Arrow International Inc
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intende...
Cardiac Devices·15 affected·May 19, 2021
High RiskFDA
Arrow International Inc
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-...
Medical Devices·3,756 affected·Mar 8, 2021
High RiskFDA
Arrow International Inc
Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly t...
Medical Devices·0 affected·Jul 6, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
Medical Devices·2,123 affected·May 20, 2020
CriticalFDA
Arrow International Inc
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Medical Devices·2,123 affected·May 20, 2020
High RiskFDA
Arrow International Inc
Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
Surgical Devices·343,105 affected·Jan 15, 2020
High RiskFDA
Arrow International Inc
FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P
Surgical Devices·343,105 affected·Jan 15, 2020