Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Hand crank serial numbers 1240 through 1247.
Products Sold
Hand crank serial numbers 1240 through 1247.
Terumo Cardiovascular Systems Corp is recalling Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. due to The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Summer of 2006.)
Recommended Action
Per FDA guidance
Consignees were notified by phone between 1/12/07 and 2/23/07 and informed replacement hand cranks would be shipped.
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