CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre

Summary

The FDA issued a Class II for CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag R by Thoratec LLC. Reason: Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the s.

Details

Product Description

CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

Lot/Code Info: UDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers. REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 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20513110, 20513111, 20513115), 10844706(20513118, 20513122, 20513123, 20513124, 20513131, 20513133), 10944546(20570873, 20570874, 20570881, 20570882, 20570883, 20570884, 20570885, 20570886, 20570887, 20570888)

Quantity Affected: 8399

Reason for Recall

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-10-10

Company