510(k) · Cleared
Recalled · Class II · 2013Heartport Endoarterial Return Cannula
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 Jun 17, 1997 after a 71-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jun 17, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 6
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971291 Heartport Endoarterial Return CannulaHeartport, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK233895 EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A…Edwards Lifesciences · 2024
Most influential descendants
Showing 1 of 1 · See all- K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…Edwards Lifesciences · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971291 | Heartport Endoarterial Return Cannula | Heartport, Inc. | 1997 | — |
| +1 | K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A… | Edwards Lifesciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | — | Heartport™ Endoarterial Return™ Cannula Named without a submission number | |
| * | — | BioMedicus® Cannula 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 |
|---|---|---|---|
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2013 | Class II | Z-1972-2013 | Nonconforming Material/Component | Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device. |
| 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. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K233895 (Edwards Lifesciences, 2024) 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?
The Endoarterial Return Cannula with and without a hemostasis valve is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
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/K971291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971291: Heartport Endoarterial Return Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971291
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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