Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100

• • Terminated Z-0221-2020 FDA Class I ·initiated 22 Aug 2019

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

• • Terminated Z-0103-2019 FDA Class II ·initiated 5 Sep 2018

  Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the motor cable bend protection.

• • Terminated Z-1901-2008 FDA Unclassified (pre-2012) ·initiated 17 Mar 2008

  Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit

510(k) Number

K020271 ↗

FDA Product Code

KFM

Device Class

Class II

Regulation

21 CFR Part 870.4360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Levitronix Centrimag Primary and Backup Consoles

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  FDA 510(k) K093832 Active Cleared 13 Jan 2010

• Centrimag Drainage Cannula Kit

  Class II

  FDA 510(k) K110983 Active Cleared 20 Jun 2011

• Levitronix 2ND Generation Centrimag Primary Console, Levitronix Monitor

  Class II

  FDA 510(k) K102129 Active Cleared 27 Aug 2010

• Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary Console

  Class II

  FDA 510(k) K083340 Active Cleared 26 Nov 2008

• Levitronix Pedimag Blood Pump, Model 201-90052

  Class II

  FDA 510(k) K090051 Active Cleared 8 Oct 2009

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