Every recall we track for ARROW INTERNATIONAL Inc. — 366 in all — plus the complaints and injury reports the public filed about them.
Arrow recalls 15 specific arterial kits and trays due to open seals on packaging. Consumers should check product references and batch numbers to determine if affected.
Arrow recalls specific Ultra 8 IAB Intra-Aortic Balloon Catheter Kits due to potential failure to inflate fully or damage in the balloon segment, which could cause serious health issues.
Arrow recalls specific models of UltraFlex Intra-Aortic Balloon Catheter Kits due to potential failure to inflate fully, damaged segments, or helium loss/blood in the pathway, which could cause serious health issues.
Arrow recalls specific models of FiberOptix Intra-Aortic Balloon Catheter Kits due to potential failure to inflate fully, damaged segments, or helium loss/blood in pathways, which could cause serious health issues.
ARROW recalls specific radial artery catheter models due to potential guidewire handle resistance causing arterial spasms or vessel injury from repeated punctures. Affected units have listed part numbers and lot numbers.
Arrow recalls specific intravascular catheter kits due to incorrect labeling on lidstock. Affected kits have batch number 13F22L0806. No immediate action needed as the hazard is labeling error, not safety risk.
Arrow recalls ErgoPack kits with incorrect labeling on lids. Affected kits have a specific batch number and may need replacement due to mislabeled product codes.
Arrow recalls ErgoPack Complete CVC kits with incorrect labeling on lidstock. Affected kits have a specific batch number and may need verification to avoid confusion.
Arrow recalls ErgoPack PICC kits with incorrect labeling on lidstock. Affected kits have a specific batch number and may need verification to avoid confusion.
Arrow recalls ErgoPack Pressure Injectable Arrowg+ard Blue Advance kits with incorrect labeling on lidstock. Affected kits have a specific batch number and style. Contact Arrow for details.
Arrow recalls ErgoPack Pressure Injectable One-Lumen PICC kits with incorrect labeling on lidstock. Affected kits may have mislabeled product codes, but no safety risk exists.
ARROW recalls specific catheter systems due to potential separation or leakage. Affected models include ASK-00620-MSH, ASK-00620-TMC, and others with unique UDI batch numbers. Stop using if you have these items.
Arrow recalls MAC Two-Lumen Central Venous Access Kits with potential for inadequate connection between Micro Clave Clear Connectors and Arrowg+ard Blue Plus Three-Lumen CVC Kits, causing possible complications.
Arrow recalls specific Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kits due to potential inadequate connection between Micro Clave Clear Connectors and the kit, which could lead to improper use.
Arrow recalls AutoCAT2 IABP pumps with potential short battery run-times. Affected units may need replacement to prevent device failure during use.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units may need replacement to prevent device failure during use.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run-times. Affected units have specific serial numbers; contact Arrow for details.
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may require immediate attention to prevent device failure.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run-times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AutoCAT2 IABP pumps with potential short battery run times. Affected units may need replacement to prevent cardiac risks.
Arrow recalls AutoCAT2 IABP pumps with potential short battery run times. Affected units have specific serial numbers and lot codes. Owners should contact Arrow for details.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AutoCAT 2 intra-aortic balloon pumps with potential short battery run times. Affected units may need replacement to prevent device failure during use.
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may need replacement to prevent device failure.
Arrow recalls AC3 Optimus IABP pumps with potential short battery run times. Affected models include NA/AJLA versions with specific serial numbers. Contact Arrow for details.
Arrow recalls AC3 Optimus Intra-Aortic Balloon Pumps with potential short battery run-times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AutoCAT 2 intra-aortic balloon pumps with potential short battery run times. Affected units may need replacement to prevent device failure during use.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AutoCAT2 IABP pumps with potential short battery run times. Affected units may need replacement due to battery issues.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AC3 Optimus IABP cardiac pumps with potential short battery run times. Affected units may require immediate action to prevent device failure during use.
Arrow recalls AC3 Optimus IABP pumps with potential short battery run times. Affected units may need replacement to prevent cardiac pump failure.
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may need replacement to prevent device failure.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AutoCAT 2 intra-aortic balloon pumps with potential short battery run times. Affected units may need replacement to prevent device failure during critical cardiac support.
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may need replacement due to battery issues.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units have specific serial numbers and lot codes. Contact Arrow for details.
Arrow recalls AutoCAT2 IABP pumps with potential short battery run times. Affected units may need replacement to prevent device failure during use.
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may need replacement to prevent device failure.
Arrow recalls AC3 Optimus IABP pumps with potential short battery life. Affected units may need replacement to prevent cardiac pump failure during use.
Arrow recalls AC3 Optimus IABP cardiac pumps with potential short battery run times. Affected units may need replacement to prevent device failure during critical medical use.
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run times. Affected units may require immediate action to prevent device failure.
Arrow recalls AutoCAT2WAVE IABP cardiac pumps with potential short battery run times. Affected units have specific serial numbers; contact Arrow for details.
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run-times. Affected units may require replacement due to battery issues.
ARROW recalls a specific midline IV kit due to mislabeled catheter size. This could lead to incorrect use if the wrong catheter is used. Affected units have a specific product code and reference number.
Arrow recalls specific models of Three-Lumen CVC due to incorrect gravity flow rates on the lidstock. Affected units may not function properly.
Arrow recalls specific 7FR Percutaneous Thrombolytic Devices due to risk of inner lumen detachment causing embolization and delayed therapy. Affected units include Lot Numbers 13F19K0564 through 13F21F1187.
Arrow recalls 7FR Percutaneous Thrombolytic Devices (PTD) with risk of inner lumen detachment causing embolization and delayed therapy. Affected units have specific product codes and lot numbers.
Arrow recalls specific 7FR Percutaneous Thrombolytic Devices due to risk of inner lumen detachment causing embolization and delayed treatment. Affected units have specific lot numbers.
Arrow recalls 7FR Percutaneous Thrombolytic Devices with risk of inner lumen detachment causing embolization. Affected units have specific product codes and lot numbers. Consumers should contact Arrow for details.
Arrow recalls temporary pacing catheter kits marketed without 510K clearance. This device is for electrophysiology studies and may not meet safety standards.
Arrow recalls a bipolar balloon electrode catheter (5 Fr. 105 cm) due to being marketed without proper regulatory approval for electrophysiology use. This device is intended for temporary medical procedures.
Arrow recalls temporary pacing catheter kits marketed without FDA 510K clearance for electrophysiology studies. Affected units have specific lot numbers and product codes.
Arrow recalls a specific pacing catheter kit due to being marketed without proper FDA 510K clearance. This device is used in electrophysiology studies. Affected units have specific lot numbers.
Arrow recalls OnControl Bone Lesion Biopsy System Tray (Product Code 9464-VC-006) due to difficulty inserting biopsy ejector rod, risking repeat procedures. Affected units sold in US/EU with specific lot numbers.
Arrow recalls AGB+ Multi-Lumen CVC Kits (CDC-45703-1A) due to potential allergic reactions in patients sensitive to chlorohexidine, silver sulfadiazine, or sulfa. Affected kits may have incorrect labeling.
Arrow recalls TheraCath Epidural Catheters with incorrect expiration dates on labels, which may increase infection risk. Affected units have product code EC-050:13F18C0518.
Arrow recalls single-shot epidural anesthesia kits with incorrect expiration dates, potentially increasing infection risk. Affected kits may not be sterile or safe beyond the correct expiration date.
Arrow recalls NextStep Retrograde Replacement Hub Set due to incorrect expiration date on product, which may lead to infection risks if used after expiration.
