Sarns™ Centrifugal Pump with X-Coating™ 164275XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00699753450325), received between May 1, 2015 and Sep 15, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE CUSTOMER RECEIVED AN EMPTY BOX OF DOLPHIN PUMP HEAD AND AT THE BOTTOM OF THE BOX THERE WAS A WRITTEN WORD "DUMMY". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474376 ↗
• MalfunctionJun 11, 2021Noise, Audible; Noise, Audible

  NEW INFORMATION RECEIVED: THE EVENT OCCURRED DURING PRIMING RECIRCULATION. CUSTOMER INDICATES THAT IT DID NOT AFFECT ANY PATIENT BECAUSE THE FAILURE WAS DURING PREPARATION OF THE EXTRACORPOREAL CIRCULATION PUMP, AT THE BEGINNING OF PRIMING RECIRCULATION, WHEN A NOISE BEGAN AS OF THE FRICTION OF THE BLADES THAT IS HAS INSIDE. THEY HAD TIME TO OPEN A SECOND CUSTOM WITHOUT STOPPING THE PROCEDURE AND THEN REPLACED THE CENTRIFUGAL PUMP. THERE WAS NO DELAY IN THE PROCEDURE AND THERE WAS NO BLOOD LOSS AS A RESULT OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11982876 ↗
• MalfunctionOct 12, 2020Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, A WHISTLE SOUND WAS NOTICED FROM THE PUMPHEAD. AS PER SUBSIDIARY, WHEN THE USER FACILITY CHANGE THE FLOW THE SOUND STOPS FOR A SHORT PERIOD OF TIME, AND THEN RESTARTS. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10666523 ↗
• MalfunctionSep 25, 2020Leak/Splash; Noise, Audible; Leak/Splash; Noise, Audible

  CORRECTED DATE INITIAL INFORMATION RECEIVED BY THE MANUFACTURER TO SEPTEMBER 1, 2020.

  Patient problems: No Patient Involvement

  MAUDE report 10588333 ↗
• MalfunctionApr 3, 2020Noise, Audible; Noise, Audible

  NEW INFORMATION RECEIVED. PER USER FACILITY THERE SEEMS TO BE A SLIGHT VIBRATION ON SOME CASES AND TO ALLEVIATE THE NOISE THEY RELIEVED THE TENSION OF THE CLAMP THAT HOLDS THE HEAD ONTO THE ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924040 ↗
• MalfunctionFeb 14, 2020Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, THE CENTRIFUGAL PUMP WAS SQUEAKY. NO CONSEQUENCES OR IMPACT TO PATIENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9713720 ↗
• MalfunctionJan 8, 2019No Flow; No Flow

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CENTRIFUGAL PUMP WAS RUNNING AT 2700 RPMS (REVOLUTION PER MINUTES) BUT WAS NOT FLOWING BLOOD. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227837 ↗
• MalfunctionDec 21, 2018Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRIMING (AFTER 1-2 MINUTES) THE USER OBSERVED GRINDING NOISE GENERATED BY THE SARNS CENTRIFUGAL PUMP HEAD. 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 8191785 ↗
• MalfunctionDec 20, 2018Noise, Audible; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP WAS EXTREMELY NOISY. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8184252 ↗
• MalfunctionMay 1, 2015Pumping Problem; Noise, Audible

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP HEAD SQUEALED. THE SQUEAL STOPPED WHEN BLOOD ENTERED THE CIRCUIT. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT; PRODUCT WAS NOT CHANGED OUT; SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4751455 ↗

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