# K971291: Heartport Endoarterial Return Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Jun 17, 1997 after 71 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Heartport™ Endoarterial Return™ Cannula: named in the summary without a submission number
- (no number) BioMedicus® Cannula: named in the summary without a submission number

## Most influential descendants
- K233895: EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); (2024), 0 descendants of its own

## Recalls of this device
- Jul 16, 2013 · Class II · Z-1972-2013: Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude Intra
- Oct 2, 2003 · Not classified · Z-0308-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0310-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0307-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0309-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0311-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

## Indications for use
The Endoarterial Return Cannula with and without a hemostasis valve is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.

Source page: https://510kreport.com/device/K971291
Methodology: https://510kreport.com/methodology