510(k) · Cleared

Recalled · Class II · 2026

Eopa Elongated One-Piece Arterial Cannula and Guidewire

K031037510(k) SpecialCleared May 13, 200342-day reviewClass II21 CFR 870.4210Recalls 6

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

Medtronic Perfusion Systems · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on May 13, 2003 as substantially equivalent to K991066 (Medtronic Vascular, 1999) and 2 other predicates after a 42-day review. Its family tree reaches back 2 generations to 1988. 11 later devices descend from it. It has been recalled 6 times.

Decided: May 13, 2003
Review: 42 days
Class: Class II
Product code: DWF
Recalls: 6
Predicates: 3

Its longest line of descent runs back 2 generations to K880421 (1988). 4 ancestors in all. 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK880421 Descending Arch CannulaDlp, Inc. · 1988
1 generation backK991066 Madtronic DLP Arterial CannulaeMedtronic Vascular · 1999
This deviceK031037 Eopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems · 2003
Descendant · cites it directly · 6 of its ownK031518 Eopa Cap Elongated One-Piece Arterial Cannula with Pressure…Medtronic Vascular · 2003
Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled
Descendant · cites it directly · 3 of its ownK110980 Centrimag Return Cannula KitLevitronix, LLC · 2011
Descendant · 2 generations on · 2 of its ownK152161 Thoratec CentriMag Return (Arterial) Cannula KitThoratec Corporation · 2015

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003high 2 (2011) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all

K031518Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models…Medtronic Vascular · 2003 · cites it directly6descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants
K110980Centrimag Return Cannula KitLevitronix, LLC · 2011 · cites it directly3descendants
K152161Thoratec CentriMag Return (Arterial) Cannula KitThoratec Corporation · 2015 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K880421	Descending Arch Cannula	Dlp, Inc.	1988	—
−1	K991066	Madtronic DLP Arterial Cannulae	Medtronic Vascular	1999	—
0 (this device)	K031037	Eopa Elongated One-Piece Arterial Cannula and Guidewire	Medtronic Perfusion Systems	2003	—
+1	K031518	Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line…	Medtronic Vascular	2003	—
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2
+1	K110980	Centrimag Return Cannula Kit	Levitronix, LLC	2011	—
+2	K152161	Thoratec CentriMag Return (Arterial) Cannula Kit	Thoratec Corporation	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2011	2	0
2012	1	0
2014	1	0
2015	1	0
2020	1	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K031037, 1988–2026Source: 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.

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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K991066	Madtronic DLP Arterial Cannulae Summary page 1 …EOPA Elongated One-Piece Arterial Cannula with Guidewire 20, 22 Fr. K991066 and KO00274 Extracorporeal Circuit with Bio-Active Surface K891687 === Pa…	Medtronic Vascular	1999	—
*	K000274	Eopa Elongated One-Piece Arterial Cannula with Guidewire	Medtronic Cardiac Surgical Products	2000	—
*	K891687	Extracorporeal Circuit with Bio-Active Surface Summary page 1 …20, 22 Fr. K991066 and KO00274 Extracorporeal Circuit with Bio-Active Surface K891687 Device Description: The EOPA Elongated One-Piece Arterial Cannulae have a flexible, thin wall wirewound body with…	Medtronic Blood Systems, Inc.	1989	10

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K031518	Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models…	Medtronic Vascular	2003	6
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5
K110980	Centrimag Return Cannula Kit	Levitronix, LLC	2011	3

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2026	Class II	Z-2809-2026	Under Investigation by firm	Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Jun 24, 2026	Class II	Z-2808-2026	Under Investigation by firm	Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Jun 24, 2026	Class II	Z-2806-2026	Under Investigation by firm	Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Jun 24, 2026	Class II	Z-2807-2026	Under Investigation by firm	Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Dec 12, 2024	Class II	Z-0985-2025	Packaging	Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Jul 24, 2015	Class II	Z-2420-2015	Packaging process control	EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

The 5 latest of 6 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 15 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K031518 (Medtronic Vascular, 2003) 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	—

What is it indicated for?

This product is intended for use with cardiopulmonary bypass as an arterial return cannula.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031037 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031037: Eopa Elongated One-Piece Arterial Cannula and Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031037

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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