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
Serial numbers 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1143-1194 and 1196 through 1245.
Products Sold
Serial numbers 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1143-1194 and 1196 through 1245.
Terumo Cardiovascular Systems Corp is recalling Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. due to The hand crank handle may separate and detach from the unit during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The hand crank handle may separate and detach from the unit during use.
Recommended Action
Per FDA guidance
Consignees were notified via letter dated 9/14/06 and mailed between 9/15/06 and 9/28/06 to check their handle type and to contact Terumo for replacement if they have Boutet-style handles. The recall was extended to additional serial numbers and consignees via additional letter sent on 11/17/06.
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 noticePage updated: Jan 10, 2026