Class 1 Device Recall CentriMag Acute Circulatory Support System Motor

• Date Initiated by Firm: August 22, 2019
• Date Posted: October 30, 2019
• Recall Status: Terminated on April 26, 2024
• Recall Number: Z-0221-2020
• Recall Event ID: 83895
• 510(K)Number: K020271
• Product Classification: Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
• Product: CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
• Code Information: U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024
• Recalling Firm/ Manufacturer: Thoratec Switzerland GMBH; Technoparkstrasse 1; Zurich Switzerland
• For Additional Information Contact: Mr. Justin Paquette; 41444451913
• Manufacturer Reason for Recall: Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
• FDA Determined Cause: Process change control
• Action: A recall letter dated August 22, 2019 was issued on Abbott letterhead and was delivered by field representative visits beginning August 22, 2019 for the U.S. consignees. Foreign consignees were notified with a letter dated August 22, 2019 containing the same content but OUS model numbers and OUS contact information. Depending on the requirements by the local regulator, the letters may have been delivered by a field representative or via certified mail. The letter identified the affected product, problem and actions to be taken.
• Quantity in Commerce: 664 units (381 U.S. and 283 OUS)
• Distribution: Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
• 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