# K000729: Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC Universal - Pathway: 510(k) (Special) - Applicant: Arrow Intl., Inc. - Decided: May 19, 2000 after 74 days - Product code: DSP (System, Balloon, Intra-Aortic And Control) - Device class: 2 - Regulation: 21 CFR 870.3535 - Recalls of this device: 27 (7 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 21 later devices descend from it; 3 cite it directly. 11 of 22 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The FDA summary names its predicate without a number. - (no number) Arrow 8Fr. 30cc and 40cc Universal Intra-Aortic Balloon Catheter Kits: named in the summary without a submission number ## Most influential descendants - K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840 (2002), 18 descendants of its own - K060309: Autocat Intra-Aortic Balloon Pump Series (2006), 14 descendants of its own - K040801: Intra-Aortic Balloon (Iab) (2004), 9 descendants of its own - K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own - K162820: AC3 Series IABP System (2017), 4 descendants of its own ## Recalls of this device - Apr 29, 2024 · Class I · Z-1879-2024: 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 i - Apr 29, 2024 · Class I · Z-1880-2024: 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 i - Feb 10, 2016 · Class I · Z-1058-2016: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Feb 10, 2016 · Class I · Z-1059-2016: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Feb 10, 2016 · Class I · Z-1056-2016: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Feb 10, 2016 · Class I · Z-1060-2016: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Feb 10, 2016 · Class I · Z-1062-2016: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. - Nov 27, 2012 · Class II · Z-1064-2013: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. - Nov 27, 2012 · Class II · Z-1065-2013: Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. - Oct 11, 2010 · Not classified · Z-0790-2011: 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. - Oct 11, 2010 · Not classified · Z-0791-2011: 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. - Oct 11, 2010 · Not classified · Z-0792-2011: 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. - Oct 11, 2010 · Not classified · Z-0793-2011: 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. - Oct 11, 2010 · Not classified · Z-0969-2011: 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. - Feb 2, 2009 · Not classified · Z-1216-2009: 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 - Feb 2, 2009 · Not classified · Z-1214-2009: 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 - Feb 2, 2009 · Not classified · Z-1219-2009: 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 - Feb 2, 2009 · Not classified · Z-1221-2009: 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 - Feb 2, 2009 · Not classified · Z-1218-2009: 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 - Feb 2, 2009 · Not classified · Z-1210-2009: 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 - Feb 2, 2009 · Not classified · Z-1215-2009: 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 - Feb 2, 2009 · Not classified · Z-1220-2009: 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 - Feb 2, 2009 · Not classified · Z-1217-2009: 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 - Feb 2, 2009 · Not classified · Z-1211-2009: 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 - Feb 2, 2009 · Not classified · Z-1212-2009: 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 - Feb 2, 2009 · Not classified · Z-1222-2009: 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 - Feb 2, 2009 · Not classified · Z-1213-2009: 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 ## Indications for use The Arrow Ultra 8 Intra-Aortic Balloon Catheters (IAB) 8 Fr 30cc and 40cc Universal is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure Source page: https://510kreport.com/device/K000729 Methodology: https://510kreport.com/methodology