Thoratec recalls CentriMag Acute Circulatory Support System Motor models due to electromagnetic interference causing motor and pump issues. Affected units may experience malfunctions.
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Thoratec is recalling specific motors for the CentriMag Extracorporeal Blood Pumping System because electromagnetic interference can cause motor and pump problems. This could lead to system malfunctions in medical use.
Electromagnetic interference can cause the motor and pump to malfunction, potentially leading to system failures during medical use. This is a risk in environments with strong electromagnetic fields.
Patients using the CentriMag system with the recalled motors are most at risk. Healthcare providers who use this device for circulatory support may also be affected.
Check for U.S. Model 102956 with UDI 07640135140078 or motor serial numbers between L05333-0001 and L06608-0024. The product is part of the CentriMag Extracorporeal Blood Pumping System.
Look for motor serial numbers between L05333-0001 and L06608-0024 on the motor.
Reach out to Thoratec Switzerland GMBH for further instructions on the recall.
U.S. Model 102956 with UDI 07640135140078 and motor serial numbers between L05333-0001 and L06608-0024.
Reports indicate electromagnetic interference can cause motor and pump issues in the CentriMag system.
The recall record does not specify a fix; users should contact Thoratec for instructions.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-0221-2020 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-0221-2020 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.