510(k) · Cleared
Recalled · 2003Heartport Endoarterial Return Cannual
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartport, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on May 10, 1996 after a 183-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 5 times.
- Decided
- May 10, 1996
- Review
- 183 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK955121 Heartport Endoarterial Return CannualHeartport, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK962858 Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem…Heartport, Inc. · 1996
Most influential descendants
Showing 1 of 1 · See all- K962858Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number…Heartport, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955121 | Heartport Endoarterial Return Cannual | Heartport, Inc. | 1996 | — |
| +1 | K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog… | Heartport, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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.
Planning a device in DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 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? (2)
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 |
|---|---|---|---|
| * | — | Bio-Medicus Cannula-Tubing Named without a submission number | |
| * | — | Tuohy-Borts Y Hemostasis Valve Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number… | 1996 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2003 | Not classified | Z-0308-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0310-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0307-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0309-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0311-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K962858 (Heartport, Inc., 1996) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannufa serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoaortic clamp catheter int6 the femoral artery.
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/K955121 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955121: Heartport Endoarterial Return Cannual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955121
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026