Overpressure Safety Valve LH130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00699753450226), received between Mar 10, 2020 and Mar 16, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K820297); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED A LEAKED VALVE. AS PER USER FACILITY, THE FIRST VALVE USED WAS A VRV-II LINE A18 PACK 75563-01, LEAKED 15MINS POST CARDIOPLEGIA, AFTER THE VENT WAS TURNED ON, AND THEY LOST 15CC OF BLOOD; THEREFORE, THEY CHANGED IT OUT WITH THE OPS VALVE WHICH ALSO LEAKED 5 ML OF BLOOD. THEY CHANGED IT OUT AGAIN WITH THE SAME PRODUCT TO COMPLETE THE CASE. *THERE WAS A KNOWN DELAY IN THE PROCEDURE *PRODUCT WAS CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY WITH 5ML BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554327 ↗
• MalfunctionAug 27, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE VALVE LEAKED. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. THE PRODUCT WAS CHANGED OUT.

  Patient problems: Insufficient Information

  MAUDE report 12379948 ↗
• MalfunctionAug 26, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THE VALVE LEAKED. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, WHETHER THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE SURGERY WAS COMPLETED SUCCESSFULLY AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. THE PRODUCT WAS CHANGED OUT.

  Patient problems: Insufficient Information

  MAUDE report 12374135 ↗
• MalfunctionAug 26, 2021Leak/Splash; Leak/Splash

  IT IS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. *PRODUCT WAS CHANGED OUT.

  Patient problems: Insufficient Information

  MAUDE report 12374095 ↗
• MalfunctionMar 17, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE VENT VALVES WERE SPLURGING BLOOD IN THE AIR. THERE WAS 5-10CC OF BLOOD LOSS. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss

  MAUDE report 9843072 ↗
• InjuryMar 10, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OVERPRESSURE SAFETY VALVE LEAKED. THE VALVE WAS BEING USED IN AN AORTIC ROOT VENT LINE AND LEAKED DURING CARDIOPLEGIA DELIVERY. THEY WERE ON REGULAR INTEGRATE FLOW WITH THE VENT ON AND WERE TOLD TO TURN OFF THE VENT. WHEN THE VENT WAS TURNED IT OFF, THAT'S WHEN THE VALVE WAS NOTED TO BE LEAKING AND IT WAS LIKE A STEADY STREAM COMING OUT FROM THE BOTTOM OF THE VALVE. THEY TOOK THE 1ST VALVE OUT AND REPLACED IT WITH A 2ND VALVE, WHICH ALSO LEAKED. THE LEAKING STOPPED ON THE 3RD VALVE REPLACEMENT. CARDIOPLEGIA FLOWS WERE ABLE TO BE RUN AT 250-300ML/MIN AND WERE SEEING PRESSURES BETWEEN 200-250MMHG. THERE WAS AN APPROXIMATE BLOOD LOSS OF 250CC. THERE WAS A DELAY OF 15 MINUTES. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss; Injury

  MAUDE report 9813736 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K820297. One submission often covers many models, so check the product and lot details in each record.

• Z-0256-2018 · Jun 27, 2017 · Terminated
  TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
• Z-0257-2018 · Jun 27, 2017 · Terminated
  Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369
• Z-1828-2015 · May 6, 2015 · Terminated
  Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed
• Z-0603-2014 · Jun 4, 2013 · Terminated
  Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line