Food, drugs, devices › Terumo Cardiovascular Systems Corporation
Device recall: Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary
FDA enforcement event 68024 is a device recall by Terumo Cardiovascular Systems Corporation of Elkton, MD, initiated 14 Apr 2014 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 7 Sep 2016. Initiation: voluntary: firm initiated. Terumo Cardiovascular Systems Corporation has 73 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Terumo Cardiovascular Systems Corporation, Elkton, MD.
Reason for recall
"During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead."
Distribution
"Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2028-2014 | Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures. | N/A | Class II | Terminated | 23 Jul 2014 |
| Z-2029-2014 | Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures. | N/A | Class II | Terminated | 23 Jul 2014 |
| Z-2030-2014 | Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01,… | 256 kits | Class II | Terminated | 23 Jul 2014 |
Context
Other enforcement events for Terumo Cardiovascular Systems Corporation
All 73 events for Terumo Cardiovascular Systems Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Sep 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.