510(k) · Cleared
Recalled · Class II · 2014X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and Dual Stage Return Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Dec 18, 2008 as substantially equivalent to K920902 (3M Health Care, Sarns, 1993) and 2 other predicates after a 38-day review. Its family tree reaches back 1 generation to 1977. 3 later devices descend from it. It has been recalled 37 times.
- Decided
- Dec 18, 2008
- Review
- 38 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 37
- Predicates
- 3
Its longest line of descent runs back 1 generation to K770429 (1977). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK770429 Cannulae, Aortic, Arch, High Flow3M Health Care, Sarns · 1977 · Recalled
- This deviceK083301 X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns…Terumo Cardiovascular Systems Corp. · 2008
- Descendant · cites it directly · 0 of its ownK132811 Sarns Soft-Flow Extended Aortic CannulaTerumo Cardiovascular Systems Corporation · 2014
- Descendant · cites it directly · 0 of its ownK132451 Sarns Soft-Flow Aortic CannulaTerumo Cardiovascular Systems Corp. · 2014
- Descendant · cites it directly · 0 of its ownK133151 Sarns High Flow Aortic Arch CannulaTerumo Cardiovascular Systems Corp. · 2014
Most influential descendants
Showing 3 of 3 · See all- K132811Sarns Soft-Flow Extended Aortic CannulaTerumo Cardiovascular Systems Corporation · 2014 · cites it directly0descendants
- K132451Sarns Soft-Flow Aortic CannulaTerumo Cardiovascular Systems Corp. · 2014 · cites it directly0descendants
- K133151Sarns High Flow Aortic Arch CannulaTerumo Cardiovascular Systems Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770429 | Cannulae, Aortic, Arch, High Flow | 3M Health Care, Sarns | 1977 | 12 |
| 0 (this device) | K083301 | X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable… | Terumo Cardiovascular Systems Corp. | 2008 | — |
| +1 | K132811 | Sarns Soft-Flow Extended Aortic Cannula | Terumo Cardiovascular Systems Corporation | 2014 | — |
| +1 | K132451 | Sarns Soft-Flow Aortic Cannula | Terumo Cardiovascular Systems Corp. | 2014 | — |
| +1 | K133151 | Sarns High Flow Aortic Arch Cannula | Terumo Cardiovascular Systems Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K920902 | Modification of Sarns Two Stage Venous CannulaSummary page 2…Return Cannula SarnsTM Dual Stage X-coated SarnsTM Venous Return K920902 1993-05-11 Dual Stage Venous Catheters… | 1993 |
| * | K905224 | Cardiopulmonary Bypass Vascular CatheterSummary page 2…Catheters SarnsTM Malleable X-coated SarnsTM Venous Return K905224 1991-02-05 Malleable Venous Catheters… | 1991 |
| * | K770429 | Cannulae, Aortic, Arch, High FlowSummary page 2…Return Catheters SarnsTM High Flow X-coated SarnsTM Aortic Arch Cannula K770429 1977-03-16 High Flow Aortic… | 1977 |
| * | — | Terumo® Dual-Stage Venous Return Cannula Named without a submission number | |
| * | — | SarnsTM Malleable Dual Stage Venous Return Catheters Named without a submission number | |
| * | — | SarnsTM Soft-FlowTM Extended Aortic Cannula Named without a submission number |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2014 | Class II | Z-2097-2014 | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications |
| May 23, 2014 | Class II | Z-2096-2014 | Process control | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications |
| Jan 7, 2013 | Class II | Z-0667-2013 | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in… |
| Jan 7, 2013 | Class II | Z-0668-2013 | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in… |
| Jan 7, 2013 | Class II | Z-0670-2013 | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in… |
| Jan 7, 2013 | Class II | Z-0671-2013 | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in… |
| Jan 7, 2013 | Class II | Z-0666-2013 | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in… |
| Jan 7, 2013 | Class II | Z-0669-2013 | Process control | Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in… |
| May 9, 2012 | Class II | Z-1834-2012 | Nonconforming Material/Component | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found… |
| Feb 23, 2012 | Not classified | Z-1294-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1297-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1313-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1302-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1310-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1299-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1309-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1300-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1305-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1301-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1307-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1293-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1298-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1292-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1306-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1296-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1287-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1291-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1288-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1304-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1290-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1311-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1312-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1295-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1303-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1314-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1308-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Feb 23, 2012 | Not classified | Z-1289-2012 | Nonconforming Material/Component | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
The 5 latest of 37 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K132811 (Terumo Cardiovascular Systems Corporation, 2014) 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. 2008, 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?
The X-coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. The X-coated Terumo® Dual-Stage Venous Return Cannula is indicated for use for adult single tube blood drainage from the right atrium and inferior vena cava (IVC) and delivery of the blood to the extracorporeal circuit during cardiopulmonary bypass. The X-coated SarnsTM Dual-Stage Venous Return Catheters…
Read the full statement (210 words)
The X-coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
The X-coated Terumo® Dual-Stage Venous Return Cannula is indicated for use for adult single tube blood drainage from the right atrium and inferior vena cava (IVC) and delivery of the blood to the extracorporeal circuit during cardiopulmonary bypass.
The X-coated SarnsTM Dual-Stage Venous Return Catheters are indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.
The SarnsTM Malleable Venous Return Catheters are indicated for venous drainage during cardiopulmonary bypass surgery: the 24, 28, 30, 32, 34, 36 and 40 Fr. are for dual cannulation of the superior and inferior vena cava; the 40 Fr. is-for single cannulation of the right atrium.
The X-coated SarnsTM Malleable Dual-Stage Venous Return Catheters are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.
The X-coated SarnsTM High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The X-coated SarnsTM Soft-FlowTM Extended Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
These devices are indicated for up to 6 hours of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083301: X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and Dual Stage Return Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083301
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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