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Terminated

Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.

FDA Recall Z-0103-2019 · Posted 2018-10-12

Recalling FirmThoratec Switzerland GMBH
Recall StatusTerminated
Product CodeKFM
Date Initiated2018-09-05
Date Terminated2021-04-28
Product Quantity1569

Reason for Recall

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.

Firm Action

On 09/05/2018, the firm mailed or hand delivered Urgent Medical Device Correction notices to customers informing them of the following: 1) A full backup system must be in the immediate vicinity of every patient supported by the circulatory support system, 2) If the circulatory support system motor stops, exchange the pump to the backup system as described in the circulatory support system Operating Manual. Improperly exchanging only the motor to a backup console could cause damage or harm, and 3) Inspection of the circulatory support system motor, including the cable, for damage should be conducted prior to use. Do not use if damaged. If the cable is damaged and not visible as part of the inspection, the console will alarm during the procedure. Firm provided customers with updated labeling and instructions for use. Firm informed customers that changes are being qualified to make the motor cable more resistant to damage and the they would inform customers when these designs become available. In addition, customers were asked to complete and return the acknowledgement form to the firm. Customers with questions are encouraged to call 1-800-456-1477; backup systems can also be rented by calling this number.

Root Cause

Device Design

Distribution Pattern

U.S.: OR, AZ, CA, ID, WA, WI, NY, MA, CT, NJ, ME, RI, IL, MI, TN, OH, IN, KY, IA, AL, FL, NC, GA, SC, VA, MD, DC, PA, WV, DE, MN, MT, NE, CO, NM, UT, AR, MO, MC, TX, OK, LA, MS, ND

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131179CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITORThoratec Corp · 2013-07-18K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052Levitronix, LLC · 2009-10-08K090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLESLevitronix, LLC · 2009-01-15K083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLELevitronix, LLC · 2008-11-26K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100Levitronix, LLC · 2003-03-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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