The Recall Desk
HighFDA (Devices)·Z-1099-2026·Announced 2026-01-21

[pending] CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 10

Pending LLM rewrite. Source: FDA_DEVICE Z-1099-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
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
Manufacturer
Thoratec LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 07640135140627
  • 07640135140603
  • 104318
  • 201-51006
  • 201-51007
  • 10007335
  • 10007336
  • 10012012
  • 10012013
  • 10012014
  • 10012015
  • 10012016
  • 10036179
  • 10036180
  • 10036181
  • 10037990
  • 10037992
  • 10037993
  • 10037995
  • 10037996

Distribution

Distributed nationwide across the United States.

Related recalls

Same category