Arrow International Inc.
Morrisville, NC
This page shows every FDA and USDA recall linked to Arrow International Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
47
Total Recalls
2022
First Recall
2024
Most Recent
Arrow Arterial Kits and Trays as follows:
(1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Cathe...
Sep 26, 2024
· Device
Open, Classified
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit,
a) REF IAB-06830-U;
b) REF IAB-06840-U;
c) REF IAB-06850...
Jun 3, 2024
· Device
Open, Classified
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit,
a) REF IAB-05830-U;
b) REF IAB-05840-U
Jun 3, 2024
· Device
Open, Classified
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit:
a) REF IAB-05830-LWS;
b) REF IAB-05840-LWS;
c) REF IAB...
Jun 3, 2024
· Device
Open, Classified
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:
a) REF AK-04220;
b) REF...
Mar 21, 2024
· Device
Open, Classified
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, the...
Oct 5, 2023
· Device
Open, Classified
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTrack...
Oct 5, 2023
· Device
Open, Classified
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision...
Oct 5, 2023
· Device
Open, Classified
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; cathet...
Oct 5, 2023
· Device
Open, Classified
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Cathet...
Sep 15, 2023
· Device
Open, Classified
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Sep 15, 2023
· Device
Open, Classified
ARROW Endurance Extended Dwell Peripheral Catheter System
Jun 21, 2023
· Device
Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pu...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pu...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pum...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac...
Dec 15, 2022
· Device
Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pum...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pu...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pu...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac p...
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
Dec 15, 2022
· Device
Open, Classified
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter i...
Dec 10, 2022
· Device
Terminated
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2...
Dec 10, 2022
· Device
Terminated
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF AS...
Oct 19, 2022
· Device
Terminated
Arrow Three-Lumen CVC
Jun 27, 2022
· Device
Terminated