Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Serial numbers 10031, 10033, 10137, 10138, 10614, 10663, 10730, 11131, 11281, 11283, 11361, 11548, 11630, 11751, 12110, 12604, 12686, 12938, 13129, 13719, 13826, 13830, 14712, 15090, 15277, 15278, 15279, 15280, 15284, 15285, 15304, 16003, 16087, 16190, 17099, 17345, 17432 and 17437 through 18122 may be affected by the problem. Serial numbers 17525, 17697, 17899, 17904, 17905 and 17913 have been corrected.
Products Sold
Serial numbers 10031, 10033, 10137, 10138, 10614, 10663, 10730, 11131, 11281, 11283, 11361, 11548, 11630, 11751, 12110, 12604, 12686, 12938, 13129, 13719, 13826, 13830, 14712, 15090, 15277, 15278, 15279, 15280, 15284, 15285, 15304, 16003, 16087, 16190, 17099, 17345, 17432 and 17437 through 18122 may be affected by the problem. Serial numbers 17525, 17697, 17899, 17904, 17905 and 17913 have been corrected.
Terumo Cardiovascular Systems Corp is recalling Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. due to Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.
Recommended Action
Per FDA guidance
As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem
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 noticePage updated: Jan 10, 2026