Z-0103-2019Class II

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

Name: Z-0103-2019 Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and...
Creator: Thoratec Switzerland GMBH
Published: 2018-09-05
License: https://open.fda.gov/license/

Thoratec Switzerland GmbH / initiated 2018-09-05 / Terminated / root cause: design

FDA source

Thoratec Switzerland GMBH began a recall of Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System on 2018-09-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0103-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-05
Posted: 2018-10-12
Terminated: 2021-04-28
Recalling firm: Thoratec Switzerland GmbH
Product: Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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.
Root cause tag: design
FDA 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 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.
Quantity in commerce: 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
Product codes and lots: UDI: 07640135140078. All serial numbers until design change is implemented to make the motor cable more resistant to damage.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0103-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0103-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-12

Product code KFM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)