Sarns™ Centrifugal Pump Adapter 824043Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00699753450417), received between May 25, 2018 and Dec 9, 2021 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2021Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE ADAPTER PLATE MADE A SQUEALING NOISE. THIS DEVICE IS REUSABLE AND EXPIRED IN JUNE 2019. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12971960 ↗
• MalfunctionDec 3, 2021Fitting Problem; Fitting Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE CENTRIFUGAL ADAPTER PLATE DOES NOT FIT TO THE CENTRIFUGAL MOTOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927794 ↗
• MalfunctionOct 22, 2021Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CENTRIFUGAL PUMP ADAPTER WAS NOISY. NO CONSEQUENCE OR IMPACT TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681775 ↗
• InjuryJul 28, 2021Decoupling; Decoupling

  ADDITIONAL INFORMATION RECEIVED, THE ISSUE WAS WITH THE CENTRIFUGAL PUMPHEAD DECOUPLED INTERNALLY BETWEEN THE MAGNET AND THE VANES. REPLACING THE PUMPHEAD WITH THE SAME ADAPTER RESOLVED THE FORWARD FLOW PROBLEM. THIS WAS ON AN S5 HEART LUNG MACHINE.

  Patient problems: Brain Injury; Hypoxia

  MAUDE report 12238662 ↗
• MalfunctionJul 29, 2020Fitting Problem; Fitting Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP ADAPTER IS NOT HOLDING THE HEAD IN PROPERLY. AS PER THE USER FACILITY, IT WAS HELD FIRMLY BY HAND FOR THE ENTIRE CASE BY A SECOND ASSISTANT, AND USED UNIT UNTIL REPLACEMENT IS RECEIVED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10338145 ↗
• MalfunctionJul 28, 2020Fitting Problem; Fitting Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP ADAPTER IS NOT HOLDING THE HEAD IN PROPERLY. AS PER THE USER FACILITY, IT WAS HELD FIRMLY BY HAND FOR THE ENTIRE CASE BY A SECOND ASSISTANT, AND USED UNIT UNTIL REPLACEMENT IS RECEIVED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10331642 ↗
• MalfunctionJul 7, 2020Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CENTRIFUGAL PUMP MADE A RATTLING NOISE. NO CONSEQUENCES OR IMPACT TO PATIENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10239670 ↗
• MalfunctionJul 7, 2020Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE SARNS DELPHIN PUMP MADE AN UNUSUAL GRINDING NOISE. AS PER THE USER FACILITY, THEY HEARD AN UNUSUAL GRINDING NOISE EMANATING FROM THE SARNS DELPHIN PUMP OR PUMP ADAPTER AND BELIEVED THAT THE NOISE WAS RELATED TO THE ADAPTER. THE PUMP WAS PRIMED THE DAY BEFORE AND WAS LEFT ON THE HEART LUNG MACHINE. THE CHIEF OF PERFUSION OPTED TO USE THE CIRCUIT AS IN ON CASE THAT MORNING AND DID NOT CHANGE THE DELPHIN PUMP OR ADAPTER. THEY DID NOTICED A MILD GRINDING SOUND FROM THE PUMP BUT ADJUSTED OR TURNED THE DELPHIN HEAD IN THE ADAPTER AND THE NOISE SUBSIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10239413 ↗
• MalfunctionJun 19, 2020Fitting Problem; Fitting Problem

  NEW INFORMATION RECEIVED THAT THE EVENT OCCURRED DURING PRIME. THERE WAS A SECOND PERFUSIONIST TO HOLD THE UNIT AND IT WAS HELD FIRMLY BY HAND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10175278 ↗
• InjuryJun 18, 2019No Flow; No Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CLINICIAN WAS UNABLE TO PROVIDE FORWARD ARTERIAL FLOW. PER USER FACILITY THEY WERE DOING MANUAL COMPRESSIONS OF THE HEART TO TRY TO GET BLOOD PRESSURE. THEY REMOVED OUR ADAPTER AND PLACED THE ADAPTER IN A HAND CRANK AND PROVIDED FORWARD ARTERIAL FLOW TO THE PATIENT. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT, PRODUCT WAS NOT CHANGED OUT, PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8708737 ↗
• MalfunctionDec 21, 2018Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, AFTER 1-2 MINUTES, A GRINDING NOISE FORM THE CENTRIFUGAL PUMP WAS OBSERVED. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191901 ↗
• MalfunctionNov 15, 2018Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A LOUD NOISE CAME FROM THE REVOLUTION PUMP WHEN THE DELPHIAN PUMP WAS ATTACHED AND WAS RUNNING AT 1900 RPM. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074860 ↗
• MalfunctionMay 25, 2018Leak/Splash; Noise, Audible; Leak/Splash; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A LEAKED WAS OBSERVED ON THE ADAPTERS AND THE SEAL STARTED TO LOOSEN UP. NO CONSEQUENCES OR IMPACT TO THE PATIENT, PRODUCT WAS CHANGED NOT OUT, PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7545978 ↗

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-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-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-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