510(k) · Cleared
Recalled · Class I · 2024Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC Universal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DSP System, Balloon, Intra-Aortic And Control
Cleared on May 19, 2000 after a 74-day review. The FDA summary names its predicate without a number. 11 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 27 times, including 7 Class I recalls.
- Decided
- May 19, 2000
- Review
- 74 days
- Class
- Class II
- Product code
- DSP
- Recalls
- 27 (7 Class I)
- Predicates
- 0
21 later devices descend from it, 3 citing it directly. 11 of the 22 devices in this family, counting this one, have a Class I recall.
- This deviceK000729 Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and…Arrow Intl., Inc. · 2000
- Descendant · cites it directly · 18 of its ownK021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor…Arrow Intl., Inc. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 14 of its ownK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Recalled (Class I)
- Descendant · cites it directly · 9 of its ownK040801 Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · Recalled
- Descendant · 2 generations on · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK162820 AC3 Series IABP SystemArrow International, Inc. · 2017 · Recalled (Class I)
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
2002high 3 (2017) · low 0 (2003)2026
Class I recalls in this family
- K021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a…cites it directly · 2002
- K200634 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2 generations on · 2020
- K063525 Datascope Fiber Optic Pressure Sensor…2 generations on · 2007
- K060309 Autocat Intra-Aortic Balloon Pump Series2 generations on · 2006
Most influential descendants
Showing 5 of 21 · See all- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…Arrow Intl., Inc. · 2002 · cites it directly18descendants
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations on14descendants
- K040801Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · cites it directly9descendants
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · 2 generations on8descendants
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC Universal | Arrow Intl., Inc. | 2000 | — |
| +1 | K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a… | Arrow Intl., Inc. | 2002 | Class I |
| +2 | K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | 2006 | Class I |
| +1 | K040801 | Intra-Aortic Balloon (Iab) | Arrow Intl., Inc. | 2004 | 13 |
| +2 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| +3 | K162820 | AC3 Series IABP System | Arrow International, Inc. | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2004 | 1 | 0 |
| 2006 | 2 | 1 |
| 2007 | 1 | 1 |
| 2009 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 3 | 2 |
| 2018 | 1 | 1 |
| 2019 | 2 | 0 |
| 2020 | 2 | 2 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
11 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSP device
- #1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Arrow 8Fr. 30cc and 40cc Universal Intra-Aortic Balloon Catheter Kits Named without a submission number |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2024 | Class I | Z-1879-2024 | Nonconforming Material/Component | 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… |
| Apr 29, 2024 | Class I | Z-1880-2024 | Nonconforming Material/Component | 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… |
| Feb 10, 2016 | Class I | Z-1058-2016 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1214-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1219-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1221-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1218-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1210-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1215-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1220-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1217-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1211-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1212-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1222-2009 | Process design | 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. |
| Feb 2, 2009 | Not classified | Z-1213-2009 | Process design | 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. |
The 5 latest of 27 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
- K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 128 Class I recalls
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 111 Class I recalls
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- Of its descendants, K021462 (Arrow Intl., Inc., 2002) has gone furthest, with 18 descendants of its own.
How does its category compare?
All DSP devicesDSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSP
1in 2025
2007high 3 (2017) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DSP
140in 2019
2007high 140 (2019) · low 73 (2017)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSP
4in 2025
2007high 33 (2022) · low 0 (2008)2026
Class I (47 since 2007) Class II/III not classified
Adverse event reports per year · DSP
7,422in 2025
2007high 7,422 (2025) · low 404 (2015)2025
MAUDE reports naming product code DSP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 461 |
| 2008 | 0 | — | 0 | 617 |
| 2009 | 2 | — | 14 | 656 |
| 2010 | 0 | — | 8 | 1,019 |
| 2011 | 2 | — | 0 | 590 |
| 2012 | 2 | — | 3 | 490 |
| 2013 | 1 | — | 0 | 495 |
| 2014 | 0 | — | 1 | 1,738 |
| 2015 | 1 | — | 0 | 404 |
| 2016 | 0 | — | 9 (9) | 419 |
| 2017 | 3 | 73 | 0 | 2,164 |
| 2018 | 1 | — | 2 (2) | 3,331 |
| 2019 | 3 | 140 | 3 | 3,552 |
| 2020 | 2 | — | 0 | 3,393 |
| 2021 | 0 | — | 5 (3) | 4,345 |
| 2022 | 0 | — | 33 (33) | 5,113 |
| 2023 | 1 | — | 0 | 6,980 |
| 2024 | 0 | — | 1 | 7,317 |
| 2025 | 1 | — | 4 | 7,422 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K000729 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000729: Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000729
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026