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ARROW INTERNATIONAL Recalls
525 recalls on record · June 27, 2012 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-4556
Hazard: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
June 24, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-
Hazard: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
June 24, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU
Hazard: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
June 24, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-
Hazard: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
June 24, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU
Hazard: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-
Hazard: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152
Hazard: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151
Hazard: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
May 20, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Hazard: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code:
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code:
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)10801902159127(17)270331(11)2
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331(11)251203(10)33F25J
Hazard: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
April 29, 2026Medical DevicesFDA
ARROW INTERNATIONAL, LLC recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347
Hazard: Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
October 2, 2024Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not
Hazard: Reports have been received regarding open seals on the packaging.
June 12, 2024Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Hazard: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
June 12, 2024Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Hazard: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
June 12, 2024Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Hazard: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
March 27, 2024Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-042
Hazard: Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
October 11, 2023Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet,
Hazard: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
October 11, 2023Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic,
Hazard: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
October 11, 2023Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intra
Hazard: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
October 11, 2023Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, R
Hazard: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
September 27, 2023Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percut
Hazard: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
September 27, 2023Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Hazard: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
June 28, 2023Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls ARROW Endurance Extended Dwell Peripheral Catheter System
Hazard: Potential for catheter separation or leakage
December 21, 2022Medical DevicesFDA
ARROW INTERNATIONAL Inc. recalls Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
Hazard: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.