510(k) · Cleared
Recalled · Class I · 2025Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-Flexii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Mar 5, 2014 as substantially equivalent to K123298 (Edwards Lifesciences, LLC, 2013) and 1 other predicate after a 36-day review. Its family tree reaches back 2 generations to 1989. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 7 times, including 4 Class I recalls.
- Decided
- Mar 5, 2014
- Review
- 36 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 7 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891576 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK891576 Fem-Flex Femoral Access Cannulation SetResearch Medical, Inc. · 1989 · Recalled
- 1 generation backK123298 Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingEdwards Lifesciences, LLC · 2013 · Recalled
- This deviceK140208 Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae)…Edwards Lifesciences, LLC · 2014
- Descendant · cites it directly · 0 of its ownK200358 Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous…Edwards Lifesciences, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K200358Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous…Edwards Lifesciences, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891576 | Fem-Flex Femoral Access Cannulation Set | Research Medical, Inc. | 1989 | 2 |
| −1 | K123298 | Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo Coating | Edwards Lifesciences, LLC | 2013 | 4 |
| 0 (this device) | K140208 | Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem… | Edwards Lifesciences, LLC | 2014 | — |
| +1 | K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula… | Edwards Lifesciences, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2004 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
1 device in this family has 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 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 |
|---|---|---|---|
| * | K123298 | Fem-Felx, Fex-Flex II Femoral Access Cannula with Duraflo CoatingSummary page 1…onary bypass vascular catheter, cannula or tubing Class 11 (21 CFR §870.421 0), Product Code DWF Predicate Devices: K123298: Femoral Access Arterial Cannuulae K1 23303: Femoral Access Venous Cannulae Device Descript… | 2013 |
| * | K123303 | Femoral Access Venous CannulaeSummary page 1…Class 11 (21 CFR §870.421 0), Product Code DWF Predicate Devices: K123298: Femoral Access Arterial Cannuulae K1 23303: Femoral Access Venous Cannulae Device Description: The Edwards Femoral Access Venous and Arterial Cannulac with/out Duraflo® c… | 2013 |
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 |
|---|---|---|---|
| K200358 | Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous… | 2020 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2025 | Class I | Z-2082-2025 | Under Investigation by firm | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| May 14, 2025 | Class I | Z-2085-2025 | Under Investigation by firm | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| May 14, 2025 | Class I | Z-2084-2025 | Under Investigation by firm | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| May 14, 2025 | Class I | Z-2083-2025 | Under Investigation by firm | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. |
| Mar 7, 2018 | Class II | Z-3032-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 7, 2018 | Class II | Z-3033-2018 | Labeling False and Misleading | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life. |
| Mar 23, 2015 | Class II | Z-1371-2015 | Process change control | Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 23.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K200358 (Edwards Lifesciences, LLC, 2020) 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. 2014, this device’s year, is highlighted.
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?
Edwards Litesciences Femoral Access Cannulae are intended for use in situations which require rapid femoral venious and arterial access for short-term (:5 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician.
Femoral access cannulae may be used in pediatric populations or aduht populations based on flow rate requirements and Individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates.
Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140208: Ferm-Flex and Fem-Flex II ( Femoral Access Arterial Cannulae) Femtrak,Vfem, and Fem-Flexii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140208
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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