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CentriMag recallZ-1099-2026 · Thoratec LLC · initiated Oct 10, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Thoratec LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process design

What the company is doing

In December 2024 Abbott sent a Product Information Letter to reinforce existing IFU. On 10/10/2025, correction notices were delivered by sales representatives to customers who were asked to do the following: Ensure the blood pump is securely locked into the motor, following the IFU. If you are unable to fully rotate and lock a blood pump into a motor, exchange the pump for a new one, and return the original pump to Abbott for a full refund or credit, please contact your Abbott Representative or Abbott Customer Service at 1-800-456-1477. Continue to follow the IFU, which can be accessed on firm website: https://manuals.eifu.abbott/en/index.html, and also follow the Pump Setup, Appendix A, in this notice, which states: The following pictures on Figure 1 clarify the IFU. After matching the grooves on the periphery of the Pump with the fittings on the motor receptacle, proceed with the following: 1. Ensuring that the pump remains flat/level with the motor/ to the pump, Rotate the pump counterclockwise until the matching groove on the pump is located in front of the locking screw. 2. Turn the locking screw until it is completely seated into the groove and the blood pump is secured in place. 3. Do not lock screw if groove is not located in front of the locking screw. 4. Always rely on visual confirmation that the pump is correctly locked in the motor, even if the "pump not inserted" alarm is not present. Communicate this information with those in your facility to whom it is relevant. Firm asks customers to notify all involved parties that support patients with affected devices. Complete and return the Acknowledgment and Receipt Form via email to [email protected] Firm has implemented an in-process manufacturing step to confirm the pumps can be fitted into the motor while continuing with the implementation of corrective actions to help ensure that new blood pumps will lock into the motor.

Recall details

Recall number
Z-1099-2026
Status
Open, Classified
Initiated by the company
Oct 10, 2025
Posted by the FDA
Jan 15, 2026
Recalling firm
Thoratec LLC
Quantity
8399
Product code
QNR
FDA submissions
K222038
Distribution
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.

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

Code information (models, lots, serial numbers)

Show the full code information (23k characters)

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. 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Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page