510(k) · Cleared
Recalled · Class II · 2017Aortic Arch Cannulas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 2, 1995 after a 294-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 2, 1995
- Review
- 294 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 4
- Predicates
- 0
7 later devices descend from it, 4 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- This deviceK943934 Aortic Arch CannulasSorin Group Italia S.R.L. · 1995
- Descendant · cites it directly · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK262052 Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
- Descendant · cites it directly · 0 of its ownK250937 Venous Return CannulaeLivaNova USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253671 Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · cites it directly3descendants
- K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 2 generations on2descendants
- K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · cites it directly0descendants
- K250937Venous Return CannulaeLivaNova USA, Inc. · 2026 · cites it directly0descendants
- K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943934 | Aortic Arch Cannulas | Sorin Group Italia S.R.L. | 1995 | — |
| +1 | K083111 | Impella 5.0 Catheter Family | Abiomed, Inc. | 2009 | 1 |
| +2 | K102726 | Cardiohelp System | Maquet Cardiopulmonary, AG | 2011 | Class I |
| +1 | K262052 | Tri Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026 | — |
| +1 | K250937 | Venous Return Cannulae | LivaNova USA, Inc. | 2026 | — |
| +1 | K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2017 | Class II | Z-2871-2017 | Process control | Identification of excess plastic on the tip of the cannula. |
| Aug 12, 2016 | Class II | Z-2756-2016 | Process control | Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned… |
| Jun 22, 2016 | Class II | Z-2147-2016 | Process control | Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45… |
| Jan 25, 2016 | Class II | Z-0813-2016 | Employee error | Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K083111 (Abiomed, Inc., 2009) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K943934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943934: Aortic Arch Cannulas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943934
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026