Sarns™ Centrifugal Pump without X-Coating™ 164275Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00699753002333), received between Jan 15, 2019 and Dec 4, 2023 — classified as 1 death, 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (10 reports).

4 other recalls cover devices cleared under the same FDA submission (K112229); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OTHER PROCEDURE, THEY NOTICED ATRIAL SEPTAL DEFECT AND ABNORMAL DRAINAGE. AS PER SUBSIDIARY, DURING THE SURGICAL PROCEDURE OF A PATIENT WITH INTERATRIAL COMMUNICATION (ATRIAL SEPTAL DEFECT - ASD) PLUS ABNORMAL DRAINAGE, THE NECESSARY FLOW CANNOT BE ACHIEVED, DESPITE HAVING THE HEAD AT 3600 RPM. ONCE THE SURGERY WAS COMPLETED AND THE PATIENT LEFT THE OPERATING ROOM, THE FOLLOWING TESTS WERE PERFORMED: WITH THE PATIENT'S CIRCUIT AS IS, 1550 RPM WAS INFUSED WITH A FLOW OF 0.250 L/MIN, WITH A CIRCUIT ONLY OF THE CENTRIFUGAL HEAD AND WATER THE RESULT WAS 240 RPM WITH A FLOW OF 1.78 L/MIN, AND FINALLY, ONLY WITH THE HEAD USED DURING SURGERY (WITH BLOOD) THE RESULT WAS 660 RPM WITH A FLOW OF 5.00 L/MIN. TECHNICAL TEAM INDICATES THAT THE EQUIPMENT IS WORKING CORRECTLY. IN ORDER TO MITIGATE ISSUE, RE-CANNULATION WAS PERFORMED WITHOUT CHANGED IN FLOW, HOWEVER, AFTER UNCLAMPING THE AORTA, THE FLOW IMPROVED. ADDITIONALLY, THE PATIENT CONDITION IS STABLE. NO KNOWN HEALTH CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY WITH KNOWN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258258 ↗
• DeathMay 24, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARTERIAL FLOW DECREASED WHEN RESTARTING THE EXTRACORPOREAL CIRCULATION PUMP. AS PER THE SUBSIDIARY, THE PROCEDURE WAS FOR A HEART SURGERY. THE EVENT OCCURRED AT THE END OF A PROCEDURE, WHICH BEGAN AT 9:00 P.M., IN A PATIENT WHO HAD AN AORTIC DISSECTION. THE PATIENT WAS VERY DELICATE, THEY REPORTED THAT HE HAD PRESENTED 8 PREVIOUS CARDIAC ARRESTS. THE INCIDENT OCCURRED AT 02:00 HRS. WHEN RESTARTING THE EXTRACORPOREAL CIRCULATION PUMP, THERE IS A DECREASE IN ARTERIAL FLOW, WHICH IS WHY THE REVOLUTIONS OF THE CENTRIFUGAL MOTOR INCREASE WITHOUT BEING ABLE TO OBTAIN MORE FLOW, FOR WHICH THEY DECIDED TO SWITCH IT TO A MANUAL MOTOR. THE PERFUSIONIST CHANGED THE (DISPOSABLE) HEAD OF THE SYSTEM 1 MOTOR AND PLACED IT ON THE EMERGENCY CRANK; HOWEVER, SHE DID NOT GIVE THE NECESSARY FLOW EITHER (SHE WAS UNABLE TO RAISE THE FLOW TO MORE THAN 2 LT/MIN). PROCEDURE WAS NOT COMPLETED. THE PATIENT EXPIRED. PRODUCT WAS CHANGED OUT WITH AN UNKNOWN MINUTES OF DELAY. THERE WAS NO BLOOD LOSS. CONCOMITANT MEDICAL PRODUCTS. OXYGENATOR BRIZIO BY NIPRO. CONTROL NP816572,NS1321. MOTOR NP164267,NS:6579. FLOW SENSOR NP638

  Patient problems: Cardiac Arrest

  MAUDE report 16996302 ↗
• MalfunctionMay 17, 2023Noise, Audible; Noise, Audible

  NOISE LIKE THE BLOW OF A PROPELLER BEGAN TO BE HEARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16949762 ↗
• MalfunctionFeb 14, 2023Crack; Particulates; Crack; Particulates

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY NOTICED A CRACKED CENTRIFUGAL DISPOSABLE PUMP. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371898 ↗
• MalfunctionOct 13, 2022Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE PUMP HEAD WAS MAKING A HIGH-PITCHED SOUND DURING RECIRCULATION. PER FACILITY, THE PUMPHEAD CONTINUED TO SQUEAL ONCE IN CONTACT WITH BLOOD. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598423 ↗
• MalfunctionNov 19, 2021Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THE CENTRIFUGAL PUMP WAS NOISY. THE PUMP WAS REMOVED, REINSTALLED WITH NO CHANGE. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. DELAY OF APPROXIMATELY 5 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845216 ↗
• MalfunctionNov 18, 2021Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIME, THE CENTRIFUGAL PUMP WAS NOISY. THE PUMP WAS REMOVED, REINSTALLED WITH NO CHANGE. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. DELAY OF APPROXIMATELY 5 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12837903 ↗
• MalfunctionMay 11, 2020Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR, DURING CARDIOPULMONARY BYPASS, THE CENTRIFUGAL PUMP MADE A SQUEAKY NOISE AFTER PRIMING AND PUMP CIRCULATED FOR 60 MINUTES. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10043199 ↗
• MalfunctionApr 20, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  NEW INFORMATION RECEIVED. THIS IS AN INTERNAL ISSUE AND NOT A COMPLAINT.

  Patient problems: No Patient Involvement

  MAUDE report 9977189 ↗
• MalfunctionFeb 12, 2020Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING SETUP, THE CENTRIFUGAL PUMP MADE A LOUD HUMMING SOUND. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 9699844 ↗
• InjuryApr 3, 2019Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A HEMOLYSIS OF BLOOD WAS FOUND IN THE CENTRIFUGAL PUMP HEAD. AS PER USER FACILITY, THEIR SETTING WAS AROUND 1000 TO 150 REVOLUTIONS PER MINUTE (RPM). NO ABNORMAL SOUND WAS HEARD ON THE CENTRIFUGAL DRIVE MOTOR DURING PROCEDURE AND WAS ADVISED THAT THEY ARE STILL USING THE SYSTEM 1 WITH THE ROLLER PUMP AS THE PRIMARY PUMP. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THERE WAS A DELAY FOR APPROXIMATELY 20 MINUTES. THE PRODUCT WAS CHANGED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A BLOOD LOSS.

  Patient problems: Blood Loss; Hemolysis; Injury

  MAUDE report 8480345 ↗
• MalfunctionFeb 14, 2019Noise, Audible; Noise, Audible

  NEW INFORMATION RECEIVED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8340574 ↗
• MalfunctionFeb 14, 2019Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS AN ABNORMAL SOUND THAT CAME FROM THE CENTRIFUGAL PUMP. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8340458 ↗
• MalfunctionJan 15, 2019Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS DURING PRIME, THERE WAS NOISE COMING FROM THE CENTRIFUGAL PUMP HEAD. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8251063 ↗
• MalfunctionJan 15, 2019Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS DURING PRIME, THERE WAS NOISE COMING FROM THE CENTRIFUGAL PUMP HEAD. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8251044 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112229. One submission often covers many models, so check the product and lot details in each record.

• Z-1235-2017 · May 27, 2015 · Terminated
  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-ste
• Z-2028-2014 · Apr 14, 2014 · Terminated
  Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
• Z-2029-2014 · Apr 14, 2014 · Terminated
  Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
• Z-2030-2014 · Apr 14, 2014 · Terminated
  Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 7