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Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

by Medtronic

510(k) K203111

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203111 Date16 Sep 2021ClearedStatusActive

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1028-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-1027-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-1023-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-1024-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-1025-2023 FDA Class II initiated 12 Dec 2022
    • Ongoing Z-1026-2023 FDA Class II initiated 12 Dec 2022

    An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

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  • Withdrawn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
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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