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

Circulatory support blood pumps recalled over locking into the motor

Thoratec is recalling 8,399 CentriMag blood pump products after reports that the pump may not fit or lock securely into the motor using the screw-in locking feature.

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: Scored 3 under the risk-of-harm criterion: the firm lists potential outcomes including delayed support, stroke and embolism, and the record reports no injuries.

Plain-English summary

The CentriMag Blood Pump and associated kits are being recalled by Thoratec LLC, covering REF 102953, 201-20003, 201-90010 and 201-90016, the CentriMag RVAD HDE Kit (REF 104318), the CentriMag Pre-connected Pack (REF CMAEK00) and the CentriMag VAD Kit among the items listed in the enforcement record.

The record states that the acute circulatory support system pump may not fit into the motor, and that reports have been received of the pump not being securely locked into the motor using the screw-in locking feature. The firm states that failure to properly lock the pump into the motor may not cause a "pump not inserted" alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic or ECMO support, stroke, embolism, and death.

The record lists 8,399 units, with UDI-DIs including 07640135140627, 07640135140603 and 05415067036414, and instructions for use revisions recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across Minnesota, Pennsylvania, Oklahoma, Florida, California, Oregon, Illinois, New York, Delaware, Georgia and New Jersey among other states. The FDA has classified the action as Class II.

The enforcement record does not report injuries. Facilities should follow Thoratec's instructions.

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 — Blood pump
Hazard
  • locking-failure
  • pump-seating
  • circulatory-support
  • missed-alarm

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.

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