Recall Z-0221-2020— Thoratec Switzerland GMBH

Name: FDA recall Z-0221-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-22

Class I · Terminated

Class I FDA medical device recall by Thoratec Switzerland GMBH, initiated 2019-08-22, terminated 2024-04-26. It names one FDA 510(k) clearance: K020271. Product: CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.. Reason: Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI)..

Recalling firm: Thoratec Switzerland GMBH
Classification: Class I
Status: Terminated
Initiated: 2019-08-22
Terminated: 2024-04-26
Firm location: Zurich, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100Levitronix, LLC·cleared 2003-03-25

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

CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

Reason for recall

Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

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