510(k) · Cleared

Recalled · 2010

Tandemheart Transseptal Cannula Set-EF, Model 5140-6221

K052570510(k) TraditionalCleared Jan 17, 2006120-day reviewClass II21 CFR 870.4210Recalls 1

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

Cardiacassist, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Jan 17, 2006 as substantially equivalent to K030398 (Cardiacassist, Inc., 2003) and 1 other predicate after a 120-day review. Its family tree reaches back 2 generations to 1986. 2 of the 13 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled once.

Decided: Jan 17, 2006
Review: 120 days
Class: Class II
Product code: DWF
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K854511 (1986). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK854511 Elecath Percutaneous Left Atrial Cannulation SetElectro-Catheter Corp. · 1986
1 generation backK030398 Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 2003
This deviceK052570 Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006
Descendant · cites it directly · 7 of its ownK063723 Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008
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 ownK093801 Impella ControllerAbiomed, Inc. · 2010
Descendant · 4 generations on · 0 of its ownK133598 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · Recalled (Class I)

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008high 2 (2008) · low 0 (2015)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 9 · See all

K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008 · cites it directly7descendants
K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · 2 generations on3descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 3 generations on2descendants
K093801Impella ControllerAbiomed, Inc. · 2010 · 2 generations on1descendant
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K854511	Elecath Percutaneous Left Atrial Cannulation Set	Electro-Catheter Corp.	1986	—
−1	K030398	Cardiacassist Transseptal Cannula Set, Model 5132-6221	Cardiacassist, Inc.	2003	—
0 (this device)	K052570	Tandemheart Transseptal Cannula Set-EF, Model 5140-6221	Cardiacassist, Inc.	2006	—
+1	K063723	Impella Recover LP 2.5 Percutaneous Cardiac Support System	Abiomed, Inc.	2008	—
+2	K083111	Impella 5.0 Catheter Family	Abiomed, Inc.	2009	1
+3	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I
+2	K093801	Impella Controller	Abiomed, Inc.	2010	—
+4	K133598	Cardiohelp System	Maquet Cardiopulmonary, AG	2014	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	1	0
2010	1	0
2011	2	1
2012	1	0
2013	1	0
2014	1	1

FIG. 1 — Lineage of K052570, 1986–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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

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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	Applicant	Decided	Recalls
*	K030398	Cardiacassist Transseptal Cannula Set, Model 5132-6221 Summary page 1 …ansseptal Cannula Set-EF Common Name: Enhanced Flow Transseptal Cannula Classification Name: Catheter Cannula Predicate Devices CardiacAssist Transseptal Cannula Set (K030398) MDT Biomedicus Femoral Cannula 96670-021 (K924642) Device Description The Tandeml-eart Transseptal Cannula Set-EF consists of…	Cardiacassist, Inc.	2003	—
*	K924642	Medtronic Bio-Medicus Femoral Cannula/Introducer Summary page 1 …Transseptal Cannula Classification Name: Catheter Cannula Predicate Devices CardiacAssist Transseptal Cannula Set (K030398) MDT Biomedicus Femoral Cannula 96670-021 (K924642) Device Description The Tandeml-eart Transseptal Cannula Set-EF consists of three components, as shown in Figure 1: (1) 21 Fr…	Medtronic Bio-Medicus, Inc.	1993	1

Also cleared against K030398: 1 other device →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K063723	Impella Recover LP 2.5 Percutaneous Cardiac Support System	Abiomed, Inc.	2008	7
K082425	Tandemheart Transseptal Cannula- EF 72	Cardiacassist, Inc.	2008	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 2, 2010	Not classified	Z-0889-2011	Other	Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications

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?

The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 17.3 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K063723 (Abiomed, Inc., 2008) has gone furthest, with 7 descendants of its own.
1 other device also cites its predicate K030398.

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	—

What is it indicated for?

The TandemHeart Transseptal Cannula Set - EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052570 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052570: Tandemheart Transseptal Cannula Set-EF, Model 5140-6221.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052570

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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