# K031037: Eopa Elongated One-Piece Arterial Cannula and Guidewire

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: May 13, 2003 after 42 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880421 (1988). 4 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991066: Madtronic DLP Arterial Cannulae, Medtronic Vascular (1999) Summary page 1.
- K000274: Eopa Elongated One-Piece Arterial Cannula with Guidewire, Medtronic Cardiac Surgical Products (2000)
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989) Summary page 1.

## Most influential descendants
- K031518: Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models 774XX, 775XX, 776XX, 777XX, 788XX, (2003), 6 descendants of its own
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K110980: Centrimag Return Cannula Kit (2011), 3 descendants of its own
- K152161: Thoratec CentriMag Return (Arterial) Cannula Kit (2015), 2 descendants of its own

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2809-2026: 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: 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: 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: 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: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- Jul 24, 2015 · Class II · Z-2420-2015: EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

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

Source page: https://510kreport.com/device/K031037
Methodology: https://510kreport.com/methodology