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Thoratec Switzerland Recalls
3 recalls on record · October 24, 2018 to July 3, 2024 · Medical Devices
Recalls by year
18
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 3, 2024Medical DevicesFDA
Thoratec Switzerland GMBH recalls 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-9
Hazard: Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
November 6, 2019Medical DevicesFDA
Thoratec Switzerland GMBH recalls CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMa
Hazard: Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
October 24, 2018Medical DevicesFDA
Thoratec Switzerland GMBH recalls Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pu
Hazard: 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.