Recall Z-0103-2019 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Thoratec Switzerland GMBH
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
| Date | Oct 12, 2018 (initiated Sep 5, 2018) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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 cond |
| Quantity | 1569 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 Levitronix, LLC, Mar 25, 2003 |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE Levitronix, LLC, Nov 26, 2008 |
| K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES Levitronix, LLC, Jan 15, 2009 |
| K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 Levitronix, LLC, Oct 8, 2009 |
| K131179 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR Thoratec Corp, Jul 18, 2013 |