Terumo recalls specific models of Advanced Perfusion System Platform for cardiopulmonary bypass use due to potential electrical short from improperly torqued screws. Affected units may need repair or replacement.
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
Terumo is recalling certain Advanced Perfusion System Platform models used in heart surgery because screws on the power manager board might not be tightened correctly. This could cause an electrical short during surgery, potentially leading to serious complications.
Screws on the power manager board were not tightened to the correct torque during manufacturing. This could cause the screw to loosen over time, leading to an electrical short in the system during use, which might disrupt critical medical procedures.
Healthcare professionals using Terumo's Advanced Perfusion System Platform for cardiopulmonary bypass procedures are most at risk. The specific units affected are those with catalog numbers listed in the recall notice.
Check for catalog number 801764 on the device. Affected units have serial numbers starting with 1522 through 1544 or specific spare parts numbers listed in the recall notice.
Identify the catalog number and serial numbers listed in the recall notice to confirm if your device is affected.
The screws on the power manager board were not torqued to specification during manufacturing, which could cause the screw to loosen over time and lead to an electrical short.
Check the catalog number and serial numbers listed in the recall notice to see if your device is affected. If it is, contact Terumo for further instructions.
The recall states that an improperly torqued screw could cause an electrical short, which might disrupt medical procedures. However, the remedy is not specified, so the risk level is use caution.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-3243-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-3243-2018 from Terumo. 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.
