VRV-II Clear Vacuum Relief Valve - Nonsterile 4004203Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10634624442037), received between Nov 8, 2017 and May 18, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE ENCOUNTERED DURING USE OF THE CPBP VACUUM RELIEF VALVE. THE REPORT STATES THAT THERE WAS A LEAK IN THE SUCKER ONE WAY VALVE IN THE YELLOW AORTIC ROOT VENT LINE AND THEY HAD TO DELAY RUNNING ONTO BYPASS TO CUT THE SIGNIFICANTLY LEAKING VALVE OUT OF THE CIRCUIT. THERE WERE NO REPORTED PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527990 ↗
• MalfunctionNov 16, 2017Leak/Splash; No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IN (B)(6) REPORTED AN ISSUE ENCOUNTERED WHILE USING THE CPBP VACUUM RELIEF VALVE. THE REPORT STATES THAT TWO VALVES LEAKED DURING USE IN A HOSPITAL. THE LEAK WAS NOTICED AT THE BASE OF THE DOME OF THE VALVE. THE VALVE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7039483 ↗
• MalfunctionNov 8, 2017Leak/Splash

  THE DEVICE DISTRIBUTOR IN (B)(4) REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS USING THE CPBP VACUUM RELIEF VALVE. THE VALVE IS A VACUUM RELIEF VALVE THAT IS SOLD BULK, NON-STERILE TO THE DISTRIBUTOR FOR FURTHER PROCESSING INTO FINAL STERILE PACKS. THE DISTRIBUTOR REPORTED THEY RECEIVED A COMPLAINT WHICH STATED THE VALVE LEAKED DURING USE. THIS OCCURRED DURING A PROCEDURE, AND THE CLINICIANS CONTINUED TO USE THE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011812 ↗
• MalfunctionNov 8, 2017Sticking; Suction Problem

  THE DISTRIBUTOR REPORTED AN ISSUE WITH THE CPBP VACUUM RELIEF VALVE. THIS VALVE WAS INTEGRATED INTO A SUCKER LINE IN OUR CARDIOVASCULAR TUBING KIT. THE REPORT STATES THAT THE VALVE GOT STUCK DURING USE BY THE DISTRIBUTOR'S CUSTOMER AND WASN'T SUCKING ANY BLOOD. THIS OCCURRED DURING A PROCEDURE, BUT WHEN THEY APPLIED SOME PRESSURE ON THE VALVE, IT CLICKED AND STARTED WORKING. THERE WAS NO DELAY TO THE PROCEDURE, NO PATIENT INJURY, AND NO BLOOD LOSS WAS REPORTED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011809 ↗