Terumo Cardiovascular Systems Corp Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 F Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 F
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14
Terumo Cardiovascular Systems Corp is recalling Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal p due to Small cracks in the blood chamber may allow air to enter the rotor of the device. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Small cracks in the blood chamber may allow air to enter the rotor of the device
Recommended Action
Per FDA guidance
Terumo notified consignees by telephone on 7/26/05 and followed by letter dated 7/28/05. Accounts are requested to return product.
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
AZ, CA, IL, KY, LA, MD, WA, WI
Page updated: Jan 10, 2026