The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
FDA Recall Z-1235-2017 · Posted 2017-02-22
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeKFM
Date Initiated2015-05-27
Date Terminated2017-02-23
Product Quantity579 units have entered into the distribution chain
Reason for Recall
Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures.
In each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks.
Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
Firm Action
Customer Notification Letter/Response Form is being sent to all affected consignees.
Root Cause
Process control
Distribution Pattern
Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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