Thoratec CentriMag Motor, Model: 102956, a component of the… recallZ-0103-2019 · Thoratec Switzerland GMBH · initiated Sep 5, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Thoratec Switzerland GMBH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0103-2019
- Status
- Terminated
- Initiated by the company
- Sep 5, 2018
- Posted by the FDA
- Oct 12, 2018
- Recalling firm
- Thoratec Switzerland GMBH
- Quantity
- 1569
- Product code
- KFM
- FDA submissions
- K020271, K083340, K090004, K090051, K131179
- 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
Product description
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Code information (models, lots, serial numbers)
UDI: 07640135140078. All serial numbers until design change is implemented to make the motor cable more resistant to damage.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CENTRIMAG MOTOR 102956Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type2 recalls4 deaths591 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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