510(k) · Cleared
Recalled · 2006Directflow Arterial 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 Mar 23, 1999 after a 14-day review. The FDA summary names its predicate without a number. It has been recalled 6 times.
- Decided
- Mar 23, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 6
- Predicates
- 0
The FDA summary names its predicate without a number.
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
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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 |
|---|---|---|---|
| * | — | DirectFlow arterial cannula Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2006 | Not classified | Z-1101-06 | Other | During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula. |
| 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.
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 DirectFlow™ arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The DirectFlow cannula also allows the hemostatic introduction and removal of vascuiar catheters such as the Heartport EndoClamp aortic catheter. The DirectFlow cannula is intended for introduction and use through a thoracic trocar or incision.
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/K990772 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990772: Directflow Arterial Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990772
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026