510(k) · Cleared

Recalled · Class II · 2014

Sarns Low Jetting Aortic Arch Cannula

K934127510(k) TraditionalCleared Feb 22, 1994181-day reviewClass II21 CFR 870.4210Recalls 41

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

3M Health Care, Sarns · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Feb 22, 1994 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 41 times.

Decided: Feb 22, 1994
Review: 181 days
Class: Class II
Product code: DWF
Recalls: 41
Predicates: 0

12 later devices descend from it, 5 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.

This deviceK934127 Sarns Low Jetting Aortic Arch Cannula3M Health Care, Sarns · 1994
Descendant · cites it directly · 6 of its ownK060101 Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006
Descendant · 2 generations on · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
Descendant · 3 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)
Descendant · 2 generations on · 1 of its ownK091542 Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009
Descendant · cites it directly · 1 of its ownK081560 Vascutek Cannula Graft, Model CGS2008SVascutek, Ltd. · 2009

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1997high 3 (2009) · low 0 (1998)2026

Class I recalls in this family

K102726 Cardiohelp System3 generations on · 2011
K133598 Cardiohelp System4 generations on · 2014

Most influential descendants

Showing 5 of 12 · See all

K060101Estech Aortic Easy Flow CannulaEndoscopic Technologies, Inc. · 2006 · cites it directly6descendants
K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · 2 generations on3descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on2descendants
K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009 · 2 generations on1descendant
K081560Vascutek Cannula Graft, Model CGS2008SVascutek, Ltd. · 2009 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K934127	Sarns Low Jetting Aortic Arch Cannula	3M Health Care, Sarns	1994	—
+1	K060101	Estech Aortic Easy Flow Cannula	Endoscopic Technologies, Inc.	2006	—
+2	K083111	Impella 5.0 Catheter Family	Abiomed, Inc.	2009	1
+3	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I
+2	K091542	Estech Easyflow Cannula with Guidewire	Endoscopic Technologies, Inc. D/B/A Estech	2009	—
+1	K081560	Vascutek Cannula Graft, Model CGS2008S	Vascutek, Ltd.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2006	1	0
2009	3	0
2011	1	1
2013	1	0
2014	3	1
2021	1	0
2025	1	0

FIG. 1 — Lineage of K934127, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060101	Estech Aortic Easy Flow Cannula	Endoscopic Technologies, Inc.	2006	6
K081560	Vascutek Cannula Graft, Model CGS2008S	Vascutek, Ltd.	2009	1
K132811	Sarns Soft-Flow Extended Aortic Cannula	Terumo Cardiovascular Systems Corporation	2014	0
K132451	Sarns Soft-Flow Aortic Cannula	Terumo Cardiovascular Systems Corp.	2014	0
K964373	Sarns Arterial Cannulae with Duraflo Treatment	3M Healthcare	1997	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 23, 2014	Class II	Z-2099-2014	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-2105-2014	Process control	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Oct 23, 2013	Class II	Z-0193-2014	Employee error	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and…
Oct 23, 2013	Class II	Z-0196-2014	Employee error	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and…
Oct 23, 2013	Class II	Z-0194-2014	Employee error	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and…
Oct 23, 2013	Class II	Z-0195-2014	Employee error	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and…
Nov 21, 2012	Class II	Z-0456-2013	Process design	The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not…
Nov 21, 2012	Class II	Z-0462-2013	Process design	The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not…
Nov 21, 2012	Class II	Z-0458-2013	Process design	The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not…
Nov 21, 2012	Class II	Z-0460-2013	Process design	The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not…
Nov 21, 2012	Class II	Z-0461-2013	Process design	The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not…
Nov 21, 2012	Class II	Z-0459-2013	Process design	The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not…
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.
Oct 19, 2005	Not classified	Z-0181-06	Other	The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.

The 5 latest of 41 recalls; the web page lists all.

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.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K060101 (Endoscopic Technologies, Inc., 2006) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DWF devices

DWF 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

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWF

4in 2024

2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007high 1,020 (2025) · low 99 (2009)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/K934127 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934127: Sarns Low Jetting Aortic Arch Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934127

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026