Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pu
FDA device recall Z-0103-2019 · posted 2018-10-12 · Terminated
Recall details
- Recalling firm
- Thoratec Switzerland GMBH
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 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
- Date initiated
- 2018-09-05
- Date posted
- 2018-10-12
- Date terminated
- 2021-04-28
- Location
- Zurich, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR (K131179) | Thoratec Corp | 2013-07-18 |
| LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 (K090051) | Levitronix, LLC | 2009-10-08 |
| LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES (K090004) | Levitronix, LLC | 2009-01-15 |
| LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE (K083340) | Levitronix, LLC | 2008-11-26 |
| LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (K020271) | Levitronix, LLC | 2003-03-25 |