# Arrow IPN000255 > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Teleflex Incorporated](https://devicerts.com/manufacturers/teleflex-incorporated) (FDA registration: United States) - Name in the registry: ARROW IPN000255 - Device class: Class II (US FDA) - FDA product code: DSP - GMDN: Intra-aortic balloon catheter (34919) ## Registrations and authorizations - **GUDID** · GUDID listing · United States · UDI-DI 00801902010759 · listed 2015-10-16 · status: Listed (GUDID: in commercial distribution) - **GUDID** · FDA 510(k) · United States · K000729 · decision 2000-05-19 · decision SESE · status: Active · from GUDID ## Recalls - Z-1879-2024 · Class I · ongoing · initiated 2024-04-29: 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. - Z-1880-2024 · Class I · ongoing · initiated 2024-04-29: 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. - Z-1059-2016 · Class I · terminated · initiated 2016-02-10: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Z-1062-2016 · Class I · terminated · initiated 2016-02-10: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Z-1060-2016 · Class I · terminated · initiated 2016-02-10: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Z-1058-2016 · Class I · terminated · initiated 2016-02-10: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Z-1056-2016 · Class I · terminated · initiated 2016-02-10: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Z-1064-2013 · Class II · terminated · initiated 2012-11-27: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. - Z-1065-2013 · Class II · terminated · initiated 2012-11-27: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. - Z-0792-2011 · · terminated · initiated 2010-10-11: SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. - Z-0969-2011 · · terminated · initiated 2010-10-11: SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. - Z-0790-2011 · · terminated · initiated 2010-10-11: SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. - Z-0793-2011 · · terminated · initiated 2010-10-11: SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. - Z-0791-2011 · · terminated · initiated 2010-10-11: SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. - Z-1215-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1222-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1221-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1220-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1214-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1213-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1211-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1217-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1219-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1218-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1216-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1210-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. - Z-1212-2009 · · terminated · initiated 2009-02-02: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume. ## Identity - Trade name: ARROW [FDA GUDID (AccessGUDID)] - Generic name: Intra-aortic balloon catheter [FDA GUDID (AccessGUDID)] - Model / Ref / Catalog: IPN000255 [FDA GUDID (AccessGUDID)]; IAB-05840-U [FDA GUDID (AccessGUDID)] ## Identifiers - Primary DI / UDI-DI: 00801902010759 [FDA GUDID (AccessGUDID)] - 510(k) Number: K000729 [FDA GUDID (AccessGUDID)] - FDA product code: DSP [FDA GUDID (AccessGUDID)] - GMDN term: Intra-aortic balloon catheter (34919) [FDA GUDID (AccessGUDID)] ## Classification - Device class: Class II [FDA GUDID (AccessGUDID)] - Regulation number: 870.3535 [FDA GUDID (AccessGUDID)] - GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)] ## Dimensions & Sizes - Size: Total Volume — 40 Milliliter [FDA GUDID (AccessGUDID)] ## Properties - Supplied sterile: Yes [FDA GUDID (AccessGUDID)] - Single use: Yes [FDA GUDID (AccessGUDID)] - Prescription use: Yes [FDA GUDID (AccessGUDID)] - Convenience kit: Yes [FDA GUDID (AccessGUDID)] - Expiration date: Yes [FDA GUDID (AccessGUDID)] - Sterilise before use: No [FDA GUDID (AccessGUDID)] - Implantable: No [FDA GUDID (AccessGUDID)] - Contains latex: No [FDA GUDID (AccessGUDID)] - Over-the-counter: No [FDA GUDID (AccessGUDID)] - Combination product: No [FDA GUDID (AccessGUDID)] - HCT/P: No [FDA GUDID (AccessGUDID)] - Premarket exempt: No [FDA GUDID (AccessGUDID)] - Lot / batch number: No [FDA GUDID (AccessGUDID)] - Serial number: No [FDA GUDID (AccessGUDID)] - Manufacturing date: No [FDA GUDID (AccessGUDID)] ## Source and citation - Cite as: Arrow IPN000255, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/arrow-iab-05840-u-4841fb3f (data as of 2026-11-15). - Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/arrow-iab-05840-u-4841fb3f - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.