RLV-2100"B" Vacuum Relief Valve 4103202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20634624413225), received between Sep 20, 2016 and Apr 7, 2017 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2017Leak/Splash

  THE DISTRIBUTOR REPORTED AN ISSUE ONE OF THEIR CUSTOMERS ENCOUNTERED DURING USE OF THE CARDIOPULMONARY SUCTION CONTROL DEVICE. THE REPORT STATED THE DEVICE LEAKED FROM THE WHITE LINE OF THE DISTRIBUTOR'S CUSTOM PERFUSION PACK. THE REPORT STATED THE LEAK WAS OBSERVED DURING PRIMING, SO IT WAS REPLACED BEFORE THE PROCEDURE BEGAN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE IS A CARDIOPULMONARY SUCTION CONTROL DEVICE SOLD IN BULK, NON-STERILE FORM TO THE DISTRIBUTOR FOR ADDITIONAL PROCESSING PRIOR TO END-USE. IT IS NOT KNOWN IF THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474096 ↗
• InjuryMar 29, 2017Leak/Splash

  THE DISTRIBUTOR REPORTED AN ISSUE ONE OF THEIR CUSTOMERS ENCOUNTERED DURING USE OF THE CARDIOPULMONARY SUCTION CONTROL DEVICE. THE REPORT STATED THE DEVICE LEAKED FROM THE RED VENT LINE OF THE DISTRIBUTOR'S CUSTOM PERFUSION PACK. THE REPORT STATED THE LEAK WAS MONITORED AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DISTRIBUTOR'S PERFORMANCE ANALYSIS STATED THEIR ANALYSIS OF THE DEVICE FOUND IT LEAKED AT APPROXIMATELY 600 MMHG INSTEAD OF THE SPECIFIED 1300 MMHG. THE DEVICE IS A CARDIOPULMONARY SUCTION CONTROL DEVICE SOLD IN BULK, NON-STERILE FORM TO THE DISTRIBUTOR FOR ADDITIONAL PROCESSING PRIOR TO END-USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6445082 ↗
• InjuryMar 29, 2017Leak/Splash

  THE DISTRIBUTOR REPORTED AN ISSUE ONE OF THEIR CUSTOMERS ENCOUNTERED DURING USE OF THE CARDIOPULMONARY SUCTION CONTROL DEVICE. THE REPORT STATED THE DEVICE LEAKED IN THE WHITE LINE OF THE DISTRIBUTOR'S CUSTOM PERFUSION PACK. THE REPORT STATED THE LEAK WAS MONITORED AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DISTRIBUTOR'S PERFORMANCE ANALYSIS STATED THEIR ANALYSIS OF THE DEVICE FOUND IT LEAKED AT APPROXIMATELY 400 MMHG INSTEAD OF THE SPECIFIED 1300 MMHG. THE DEVICE IS A CARDIOPULMONARY SUCTION CONTROL DEVICE SOLD IN BULK, NON-STERILE FORM TO THE DISTRIBUTOR FOR ADDITIONAL PROCESSING PRIOR TO END-USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6445076 ↗
• InjuryNov 14, 2016Suction Problem; Difficult to Open or Close; Pressure Problem

  THE DISTRIBUTOR REPORTED AN ISSUE ONE OF THEIR CUSTOMERS ENCOUNTERED DURING USE OF THE CARDIOPULMONARY SUCTION CONTROL DEVICE. THE REPORT STATED THE DEVICE WAS PART OF A "SUCKER LINE", A NEGATIVE PRESSURE LINE USED DURING AN ECMO PROCEDURE. THE REPORT STATED THAT THE ONE-WAY VALVE WAS STUCK OPEN, AND TO RESOLVE THE ISSUE A CAP WAS PLACED ON THE NEGATIVE PRESSURE RELEASE AND ANOTHER VALVE WAS PLACED PROXIMAL TO THE OPEN VALVE. THE REPORT STATED THAT BLOOD WAS LOST THAT REQUIRED A BLOOD TRANSFUSION TO THE PATIENT AND AN ACUTE PRESSURE DROP WAS OBSERVED AS A RESULT OF THE ALLEGED EVENT. THE REPORT WAS COMPLETED AND NO FURTHER PATIENT IMPACT WAS REPORTED. THE DEVICE WAS DISCARDED BY THE END-USER AND NOT RETURNED TO THE DISTRIBUTOR OR MANUFACTURER FOR EVALUATION. THE DEVICE IS A CARDIOPULMONARY SUCTION CONTROL DEVICE SOLD IN BULK, NON-STERILE FORM TO THE DISTRIBUTOR FOR ADDITIONAL PROCESSING PRIOR TO END-USE.

  Patient problems: Blood Loss

  MAUDE report 6100637 ↗
• InjurySep 20, 2016Fluid/Blood Leak

  THE FOREIGN DISTRIBUTOR (B)(6) REPORTED AN ISSUE ENCOUNTERED WITH THE USE OF THE CARDIOPULMONARY SUCTION CONTROL DEVICE FROM ONE OF THEIR CUSTOMERS. THE REPORT STATED THAT THE DEVICE LEAKED FOR APPROXIMATELY 2-3 MINUTES DURING USE. THE REPORT STATED THE DEVICE WAS REMOVED FROM USE AND A DIFFERENT ONE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS GIVEN A TRANSFUSION TO ADDRESS THE BLOOD LOSS (VOLUME NOT PROVIDED) WITH NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE IS A SUCTION CONTROL DEVICE SOLD IN BULK NON-STERILE FORM TO THE DISTRIBUTOR FOR ADDITIONAL PROCESSING PRIOR TO END-USE.

  Patient problems: Blood Loss

  MAUDE report 5963860 ↗