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TandemHeart 2100-0113

by Cardiacassist, Inc. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814112020043 UDI-DIDate10 Oct 2015ListedStatusWithdrawn

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1950-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1954-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1949-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1948-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1951-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1955-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1953-2020 FDA Class II initiated 6 Mar 2020
    • Terminated Z-1952-2020 FDA Class II initiated 6 Mar 2020

    Failure to prime due to an assembly error

Specification

GUDID

Trade Name
TandemHeart
Generic Name
Cardiopulmonary bypass system centrifugal pump
Model / Reference
2100-0113
Primary DI / UDI-DI
00814112020043
510(k) Number
FDA Product Code
KFM
GMDN Term
Cardiopulmonary bypass system centrifugal pump
Device Class
Class II
Regulation Number
870.4360
Commercial Distribution
Not in Commercial Distribution

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See all devices from Cardiacassist, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No