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Eopa Elongated One-Piece Arterial Cannula and Guidewire

by Medtronic Perfusion Systems

510(k) K031037

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK031037 Date13 May 2003ClearedStatusActive

Recalls

6 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2809-2026 FDA Class II initiated 24 Jun 2026
    • Ongoing Z-2808-2026 FDA Class II initiated 24 Jun 2026
    • Ongoing Z-2806-2026 FDA Class II initiated 24 Jun 2026
    • Ongoing Z-2807-2026 FDA Class II initiated 24 Jun 2026

    Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.

    • Ongoing Z-0985-2025 FDA Class II initiated 12 Dec 2024

    Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

    • Terminated Z-2420-2015 FDA Class II initiated 24 Jul 2015

    EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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