Thoratec Switzerland Gmbh
FDA adverse event reports naming Thoratec Switzerland Gmbh as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: THORATEC SWITZERLAND GMBH.
- Total reports
- 2,616
- Deaths
- 94
- Injuries
- 769
- Malfunctions
- 1,753
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Control, Pump Speed, Cardiopulmonary BypassDWA1,201
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM1,032
- Blood Pump For Ecmo, Long-Term (> 6 Hours) UseQNR329
- Ventricular (Assist) BypassDSQ25
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF17
- Bag, Polymeric Mesh, PacemakerDSW5
- Oxygenator, Cardiopulmonary BypassDTZ5
- Right Ventricular Bypass (Assist) DeviceOJE2
Recent recalls
- 2024-06-27Open, ClassifiedProcess control
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
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.
- 2019-10-30TerminatedProcess change control
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
- 2018-10-12TerminatedDevice Design
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
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.
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