Quick Facts at a Glance
- Recall Date
- October 10, 2025
- Hazard Level
- HIGH
- Brand
- Thoratec
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Thoratec
- Product type
- Blood Pump
- Model numbers
- 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 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 10, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Thoratec LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The CentriMag Blood Pump is designed to provide acute circulatory support in patients requiring ECMO (extracorporeal membrane oxygenation) therapy. Healthcare providers use this device for patients with severe heart or lung failure.
Why This Is Dangerous
The device may not securely lock into the motor, which can prevent it from functioning properly. This malfunction could cause serious health complications if not addressed immediately.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses significant safety risks to patients relying on this device for life-sustaining support, creating urgency for immediate action.
Practical Guidance
How to identify if yours is affected
- Check the model number on your CentriMag Blood Pump against the recalled models listed in the recall notice.
- Verify the serial number of your device, if applicable, to confirm if it is part of the recall.
- Consult your healthcare provider if you are unsure about your device's status.
Where to find product info
The model number and serial number can typically be found on the device's labeling or packaging.
What timeline to expect
Expect a timeline of 4-8 weeks for refund processing once the return is initiated.
If the manufacturer is unresponsive
- Contact Thoratec LLC again for further clarification.
- Document all communications with the manufacturer regarding the recall.
How to prevent similar issues
- When purchasing medical devices, ensure they have the latest safety certifications.
- Keep informed on device recalls and safety alerts from the FDA.
- Consult with healthcare professionals about the latest devices and technologies.
Documentation advice
Keep records of your purchase, any correspondence with the manufacturer, and photographs of the device for your records.
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Product Details
The recall includes CentriMag Blood Pump models REF: 102953, 201-20003, 201-90010, 201-90016, and others. These devices were distributed worldwide, including in 50 states and numerous countries such as Canada and Germany. Units were sold starting in the year prior, with specific models identified in the recall.
Key Facts
- Recall date: October 10, 2025
- Quantity recalled: 8,399 units
- Affected models include REF: 102953, 201-20003
- Risk of serious health complications, including death
- Distributed worldwide, including across the US
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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