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Thoratec Switzerland GMBH: FDA-registered device maker in Zurich, Switzerland, 5 510(k) clearances and 1 PMA approval

Name: Thoratec Switzerland GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Thoratec Switzerland GMBH is registered with the FDA (registration 3003306248) in Zurich, Switzerland. It lists 6 device types. The FDA files 5 510(k) clearances and 1 PMA approval under its listings, the newest dated January 26, 2024. 3 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3003306248
Address: Technoparkstrasse 1, Zurich, Switzerland, CH-8005
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer, Specification developer
First device listed: February 23, 2018
Registered through: 2027
Brand names listed: 2nd Generation CentriMag Primary Console and Monitor, CIRCULAR OXYGENATOR BRACKET LARGE, CIRCULAR OXYGENATOR BRACKET MEDIUM, CIRCULAR OXYGENATOR BRACKET SMALL, CentriMag Blood Pump, CentriMag Blood Pump, CentriMag Acute Circulatory Support System, CentriMag Circulatory Support System, CentriMag Motor Bracket (45 Degree) and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory Equipment, Cardiopulmonary Bypass	KRI	1	Manufacturer, Specification developer	accessdata.fda.gov
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	QNR	2	Manufacturer	accessdata.fda.gov
Control, Pump Speed, Cardiopulmonary Bypass	DWA	2	Manufacturer	accessdata.fda.gov
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	KFM	2	Manufacturer	accessdata.fda.gov
Right Ventricular Bypass (Assist) Device	OJE	f	Manufacturer	accessdata.fda.gov
Ventricular (Assist) Bypass	DSQ	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 26, 2024	K234118	CentriMag Acute Circulatory Support System	QNR	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
December 8, 2022	K222038	CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System	QNR	Substantially Equivalent	Abbott (Formerly Thoratec Corporation)	accessdata.fda.gov
August 27, 2010	K102129	LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR	DWA	Substantially Equivalent	Levitronix, LLC	accessdata.fda.gov
October 8, 2009	K090051	LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052	KFM	Substantially Equivalent	Levitronix, LLC	accessdata.fda.gov
March 25, 2003	K020271	LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100	KFM	Substantially Equivalent	Levitronix, LLC	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 6, 2019	P170038	CentriMag Circulatory Support System	DSQ	32	October 2, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 22, 2024	94588	Class II	Ongoing	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.	accessdata.fda.gov
August 22, 2019	83895	Class I	Terminated	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).	accessdata.fda.gov
September 5, 2018	80917	Class II	Terminated	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.	accessdata.fda.gov

Compare with other makers

Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.