Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 0976 and 0979.
Products Sold
Serial numbers 0976 and 0979.
Terumo Cardiovascular Systems Corp is recalling Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. due to Six inch roller pumps were mislabeled as 4 inch roller pumps.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Six inch roller pumps were mislabeled as 4 inch roller pumps.
Recommended Action
Per FDA guidance
The six inch roller pump labels were corrected during in-house servicing on 10/6/05 and 10/24/05. A corrected nameplate for the 4 inch roller pump with the incorrect serial number was printed and shipped to the foreign distributor on 10/11/06, and applied in the field by the international distributor on 10/18/06.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI
Page updated: Jan 10, 2026