Terumo recalls 4-inch roller pumps with potential shaft failure causing noise and pump stoppage during blood circulation procedures. Affected units have specific serial numbers and catalog numbers.
These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pulley of the roller pump. Prolonged use of a roller pump in this condition could lead to an eventual pump stop, resulting in the inability to create pump flow due to pulley loosening and drive belt damage.
Terumo is recalling a specific model of blood pump used in medical procedures due to a risk of pump failure from shaft issues. This could stop blood circulation during critical surgeries if the pump fails.
The pump shafts may fail at the thread where a locknut is installed, causing unusual noise. This happens when the unsecured shaft end contacts the rotating pulley. Prolonged use could lead to pump stoppage and blood circulation issues.
Medical professionals using the Terumo Advanced Perfusion System 1 Roller Pump for blood circulation procedures are most at risk. Patients undergoing surgeries with this pump may be affected if the pump fails.
Check for the catalog number 816570 and serial numbers starting with 6860 through 6953. The pump is used for blood circulation procedures in medical settings.
Listen for unusual noise during operation, which may indicate shaft contact with the pulley.
Immediately stop using the pump if you hear unusual noise, as this could lead to pump failure.
The catalog number is 816570.
Serial numbers from 6860 to 6953.
The recall record does not mention a fix or remedy.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1108-2020 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1108-2020 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.
