Recall Z-1954-2020— Cardiac Assist, Inc

Name: FDA recall Z-1954-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-06

Class II · Terminated

Class II FDA medical device recall by Cardiac Assist, Inc, initiated 2020-03-06, terminated 2020-11-20. It names one FDA 510(k) clearance: K110493. Product: TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.. Reason: Failure to prime due to an assembly error.

Recalling firm: Cardiac Assist, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-03-06
Terminated: 2020-11-20
Firm location: Pittsburgh, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K110493 — TANDEMHEART PUMPCardiacassist, Inc.·cleared 2011-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.

Reason for recall

Failure to prime due to an assembly error

Data sourced from openFDA. This site is unofficial and independent of the FDA.