--- title: "ARROW INTERNATIONAL Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search ARROW INTERNATIONAL Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/arrow-international-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # ARROW INTERNATIONAL Inc. recall records **43** reported ongoing 47 records in this archive. Latest source date Jul 26, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 26, 2024 FDA device enforcement ### [Arrow 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...](https://isitonrecall.com/recall/fda-device-z-3299-2024-arrow-arterial-kits-and-trays-as-follows-1-arrow-arterial-access-tray-with-0-025-spring-wire-guide-c/) Reports have been received regarding open seals on the packaging. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution. [Official source for Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3299-2024%22) Apr 29, 2024 FDA device enforcement ### [Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS](https://isitonrecall.com/recall/fda-device-z-1878-2024-arrow-fiberoptix-intra-aortic-balloon-catheter-kit-a-ref-iab-05830-lws-b-ref-iab-05840-lws-c-ref-iab/) 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 l... Class I Reported ongoing Distribution: Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, ... [Official source for Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1878-2024%22) Apr 29, 2024 FDA device enforcement ### [Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U](https://isitonrecall.com/recall/fda-device-z-1879-2024-arrow-ultraflex-intra-aortic-balloon-catheter-kit-a-ref-iab-06830-u-b-ref-iab-06840-u-c-ref-iab-0685/) 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 l... Class I Reported ongoing Distribution: Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, ... [Official source for Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1879-2024%22) Apr 29, 2024 FDA device enforcement ### [Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U](https://isitonrecall.com/recall/fda-device-z-1880-2024-arrow-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 l... Class I Reported ongoing Distribution: Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, ... [Official source for Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1880-2024%22) Feb 12, 2024 FDA device enforcement ### [ARROW 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 AS...](https://isitonrecall.com/recall/fda-device-z-1267-2024-arrow-quickflash-radial-artery-catherization-wire-guide-catheter-part-numbers-a-ref-ak-04220-b-ref-a/) 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 immedia... Class I Reported ongoing Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE, AR, AT, AU, BE, BH, BR, CA, CN, CO, CY, DE, EC, EE, ES, FR, GR, HK, HR, IT, KW, LB, LU, MX, MY, NL... [Official source for ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-042...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1267-2024%22) Aug 10, 2023 FDA device enforcement ### [Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-...](https://isitonrecall.com/recall/fda-device-z-0001-2024-arrow-ergopack-pressure-injectable-arrowg-ard-blue-advance-two-lumen-picc-pre-loaded-with-arrow-vps/) This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Class I Reported ongoing Distribution: US [Official source for Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0001-2024%22) Aug 10, 2023 FDA device enforcement ### [Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days](https://isitonrecall.com/recall/fda-device-z-0002-2024-arrow-ergopack-complete-pressure-injectable-arrowg-ard-blue-plus-four-lumen-cvc-ref-cdc-42854-pcn1a/) This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Class I Reported ongoing Distribution: US [Official source for Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0002-2024%22) Aug 10, 2023 FDA device enforcement ### [Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days](https://isitonrecall.com/recall/fda-device-z-0003-2024-arrow-pressure-injectable-arrowg-ard-blue-plus-four-lumen-cvc-ref-cdc-45854-p1a-catheter-intravascul/) This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Class I Reported ongoing Distribution: US [Official source for Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intr...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0003-2024%22) Aug 10, 2023 FDA device enforcement ### [Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic,...](https://isitonrecall.com/recall/fda-device-z-0004-2024-arrow-ergopack-pressure-injectable-arrowg-ard-blue-advance-three-lumen-picc-pre-loaded-with-arrow-vp/) This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Class I Reported ongoing Distribution: US [Official source for Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0004-2024%22) Aug 10, 2023 FDA device enforcement ### [Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular](https://isitonrecall.com/recall/fda-device-z-2590-2023-arrow-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. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2590-2023%22) Aug 10, 2023 FDA device enforcement ### [Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter](https://isitonrecall.com/recall/fda-device-z-2591-2023-arrow-ergopack-pressure-injectable-two-lumen-picc-pre-loaded-with-arrow-vps-stylet-ref-cdc-35552-vps/) This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-3555...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2591-2023%22) May 19, 2023 FDA device enforcement ### [ARROW Endurance Extended Dwell Peripheral Catheter System](https://isitonrecall.com/recall/fda-device-z-1826-2023-arrow-endurance-extended-dwell-peripheral-catheter-system/) Potential for catheter separation or leakage Class I Reported ongoing Distribution: Nationwide distribution. International distribution to Canada. [Official source for ARROW Endurance Extended Dwell Peripheral Catheter System](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1826-2023%22) Oct 27, 2022 FDA device enforcement ### [Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer](https://isitonrecall.com/recall/fda-device-z-0351-2023-arrow-mac-two-lumen-central-venous-access-kit-fr-use-with-7-7-5-fr-catheters-ref-ask-11242-upm1-cath/) There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit. Class I Reported terminated Distribution: US Distributor in states of: FL, GA, KY, OH, PA and WV. [Official source for Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0351-2023%22) Oct 27, 2022 FDA device enforcement ### [Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-457...](https://isitonrecall.com/recall/fda-device-z-0352-2023-pressure-injectable-arrowg-ard-blue-plus-three-lumen-cvc-kit-ref-numbers-a-ask-42703-ns-b-ask-42703/) There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit. Class I Reported terminated Distribution: US Distributor in states of: FL, GA, KY, OH, PA and WV. [Official source for Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) AS...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0352-2023%22) Oct 17, 2022 FDA device enforcement ### [Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump](https://isitonrecall.com/recall/fda-device-z-0426-2023-arrow-autocat2-intra-aortic-balloon-pump-autocat-2-iapb-ref-iap-0400-ipn000302-cardiac-pump/) There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. Class I Reported ongoing Distribution: Worldwide [Official source for Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0426-2023%22) Oct 17, 2022 FDA device enforcement ### [Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump](https://isitonrecall.com/recall/fda-device-z-0427-2023-arrow-autocat2-intra-aortic-balloon-pump-autocat2-iapb-refurbished-ref-iap-0400x-ipn000311-cardiac-p/) There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. Class I Reported ongoing Distribution: Worldwide [Official source for Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0427-2023%22) Oct 17, 2022 FDA device enforcement ### [Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump](https://isitonrecall.com/recall/fda-device-z-0428-2023-arrow-autocat2-intra-aortic-balloon-pump-aeroautocat2-ref-iap-0435-ipn000312-cardiac-pump/) There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. Class I Reported ongoing Distribution: Worldwide [Official source for Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0428-2023%22) Oct 17, 2022 FDA device enforcement ### [Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump](https://isitonrecall.com/recall/fda-device-z-0429-2023-arrow-autocat2-intra-aortic-balloon-pump-autocat2-wave-ref-iap-0500-ipn000320-cardiac-pump/) There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. Class I Reported ongoing Distribution: Worldwide [Official source for Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0429-2023%22) Oct 17, 2022 FDA device enforcement ### [Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump](https://isitonrecall.com/recall/fda-device-z-0430-2023-arrow-autocat2-intra-aortic-balloon-pump-autocat2-wave-refurbished-ref-iap-0500x-ipn000328-cardiac-p/) There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. Class I Reported ongoing Distribution: Worldwide [Official source for Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), c...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0430-2023%22) Oct 17, 2022 FDA device enforcement ### [Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump](https://isitonrecall.com/recall/fda-device-z-0431-2023-arrow-autocat2-intra-aortic-balloon-pump-aeroautocat-2-wave-ref-iap-0535-ipn000329-cardiac-pump/) There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. Class I Reported ongoing Distribution: Worldwide [Official source for Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0431-2023%22) ## Reasons in these listed records - Reports have been received regarding open seals on the packaging. - 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 br... - 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 consequenc... - This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. These examples come from this result page and are not a ranking of every recall reason. ## Checking ARROW INTERNATIONAL Inc. ### Is there a recall on arrow international inc. right now? This archive contains 47 records, including 43 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search ARROW INTERNATIONAL Inc.](https://isitonrecall.com/check/?q=ARROW%20INTERNATIONAL%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)