ARROW INTERNATIONAL Inc.
9 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for ARROW INTERNATIONAL Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-02FDA-DeviceClass IIArrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial
Reports have been received regarding open seals on the packaging.
- 2024-06-12FDA-DeviceClass IArrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
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.
- 2024-06-12FDA-DeviceClass IArrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
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.
- 2024-06-12FDA-DeviceClass IArrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
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.
- 2024-03-27FDA-DeviceClass IARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l) REF RA-04220-W
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.
- 2023-10-11FDA-DeviceClass IArrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- 2023-09-27FDA-DeviceClass IIArrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- 2023-09-27FDA-DeviceClass IIArrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- 2023-06-28FDA-DeviceClass IARROW Endurance Extended Dwell Peripheral Catheter System
Potential for catheter separation or leakage
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