Skip to content

Affinity Pixie™ Oxygenator with Balance™ Biosurface - Venous Reservoir with Balance™ Biosurface (Model BBP241)

by Medtronic, Inc.

510(k) K183511

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

10 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183511 Date18 Mar 2019ClearedStatusActive

Recalls

10 recalls · FDA

  • 10 recalls, same reason

    • Terminated Z-1198-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1191-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1192-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1195-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1194-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1199-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1196-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1197-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1190-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511
    • Terminated Z-1193-2021 FDA Class I initiated 4 Feb 2021 on shared 510(k) K183511

    Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Models / Variants
Venous Reservoir with Balance™ Biosurface (Model BBP241)
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →