Thoratec LLC is recalling 8,399 CentriMag Blood Pumps and associated acute circulatory support system kits. These medical devices may not fit properly into the motor or may fail to lock securely using the screw-in locking feature. If the pump is not properly locked, the system may fail to sound the "pump not inserted" alarm, potentially leading to critical equipment failure during life-sustaining treatment.
A pump that is not securely locked can generate excessive heat or create particulate matter. This malfunction can cause a delay in hemodynamic or ECMO support, potentially resulting in stroke, embolism, or death.
CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System. IFU Revisions: ARTEN600254920 Rev C, ARTEN600254958 Rev C, ARTEN100174794 Rev B, ARTEN600230157 Rev D, ARTEN600254935 Rev C, ARTEN600254936 Rev C, ARTEN600332205 Rev A, ARTEN600332207 Rev A.
No associated un-expired batches/serial numbers reported for this REF in raw data.
Includes several sub-batches identified by prefixes: CMAEK00, 10438711, 10451609, 10451610, 10451615, 10451617, 10463759, 10463760, 10552471, 10552472, 10552475, 10552484, 10552486, 10552487, 10574868, 10574869, 10574872, 10574873, 10574875, 10574876, 10623548, 10623549, 10623550, 10623551, 10623552, 10623553, 10623554, 10649991, 10649992, 10649993, 10649994, 10649995, 10671740, 10671741, 10671743, 10671745, 10715960, 10715961, 10715962, 10779655, 10779656, 10794262, 10794264, 10794266, 10794268, 10794269, 10805521, 10805522, 10805523, 10805524, 10805525, 10834379, 10834385, 10834397.
No associated un-expired batches/serial numbers reported for these REF numbers in raw data.
Includes several sub-batches identified by prefixes: 10485765, 10485769, 10506836, 10506837, 10506839, 10506840, 10506841, 10547650, 10547655, 10605980, 10605982, 10605987, 10605988, 10605989, 10671735, 10671737, 10671738, 10715950, 10715951, 10715952, 10715956, 10715957, 10715958, 10757855, 10757856, 10757858, 10757859, 10794274, 10805518, 10805519, 10844705, 10844706, 10944546.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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