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FDA-Device2026-01-21Class IIPROCESSING DEFECT

Thoratec CentriMag Blood Pump recalled for improper motor locking risk

Thoratec
OTHERNationwide distribution

Check Thoratec CentriMag Blood Pump serial numbers

Thoratec CentriMag blood pump components used in acute circulatory support and ECMO systems may not lock securely into the motor. If the pump fails to lock properly, the system may not generate an alarm, which could delay critical heart support or cause serious complications.

  • Check if your hospital or facility has the affected CentriMag Blood Pump (REF 102953 and other listed references)
  • Compare your serial number to the FDA recall list
  • Contact Thoratec immediately if you have an affected unit
  • Do not use the pump until you confirm it is not on the recall list and verify secure motor locking
Hazard

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.

Sold states
Worldwide - US Nationwide distribution including in the states of MN, PA, OK, FL, CA, OR, IL, NY, DE, GA, NJ, NC, WI, OH, AZ, AR, TX, TN, MO, MA, MT, KY, NE, WV, VA, ME, ND, AL, CO, DC, MS, IN, MI, CT, SC, WA, NM, MD, HI, ID, IA, LA, UT, RI, NV and the countries of Algeria, Australia, Austria, Bahrain, CANADA, Cayman Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Italy, Jordan, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Oman, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.
Affected count
8399
Manufactured in
6035 Stoneridge Dr, Pleasanton, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2026

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