Thoratec recalls CentriMag Blood Pumps (REFs 102953, 201-20003, 201-90010, 201-90016) and CentriMag RVAD HDE KIT (REF 104318) due to risk of pump not securely locking into motor, which could cause particulate, heat, or serious complications.
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.
Thoratec is recalling certain CentriMag Blood Pumps and CentriMag RVAD HDE Kits because they may not lock securely into the motor. This could lead to pump alarms, increased heat, or serious complications like stroke or death. Affected units have specific reference numbers listed in the recall.
The pump may not fit properly into the motor or fail to lock securely using the screw-in feature. This can cause pump alarms, increased heat, particulate release, and potentially lead to stroke, embolism, or death in patients requiring ECMO support.
Patients using CentriMag Blood Pumps or CentriMag RVAD HDE Kits for ECMO support are most at risk. Healthcare providers and patients with these devices should check if their units are affected.
Check for reference numbers: CentriMag Blood Pump (REFs 102953, 201-20003, 201-90010, 201-90016), CentriMag RVAD HDE KIT (REF 104318), or CentriMag Pre-connected Pack (REF CMAEK00).
Look for reference numbers on the pump or kit: 102953, 201-20003, 201-90010, 201-90016 for Blood Pumps; 104318 for RVAD HDE Kits.
If your unit has an affected reference number, contact Thoratec for instructions on how to fix or replace the pump.
The CentriMag Blood Pump is used with CentriMag Acute Circulatory Support System for ECMO (Extracorporeal Membrane Oxygenation) support in patients requiring temporary life support.
No, but you should check if your pump has an affected reference number. If it does, contact Thoratec for instructions to fix or replace the pump.
If the pump doesn't lock securely, it may cause pump alarms, increased heat, particulate release, or serious complications like stroke or death in patients requiring ECMO support.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-1099-2026 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-1099-2026 from Thoratec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
