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U.S. Department of Health and Human Services

Class 2 Device Recall Thoratec CentriMag Motor, Model: 102956

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  Class 2 Device Recall Thoratec CentriMag Motor, Model: 102956 see related information
Date Initiated by Firm September 05, 2018
Date Posted October 12, 2018
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0103-2019
Recall Event ID 80917
510(K)Number K020271  K083340  K090004  K131179  K090051  
HDE Number H070004 
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Code Information UDI: 07640135140078. All serial numbers until design change is implemented to make the motor cable more resistant to damage.
Recalling Firm/
Manufacturer		 Thoratec Switzerland GMBH
Technoparkstrasse 1
Zurich Switzerland
For Additional Information Contact Justin Paquette
615-756-6293
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KFM and Original Applicant = LEVITRONIX LLC.
510(K)s with Product Code = KFM and Original Applicant = THORATEC CORP
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