PeritX 50-9210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403222726), received between Apr 3, 2026 and Apr 11, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER ON MARCH 11, 2026, THAT THE PERITX DRAINAGE BAG WAS LEAKING DURING USE, DESPITE CONFIRMATION THAT BOTH THE DRAINAGE END AND THE CLAMP WERE SECURELY CLOSED. DURING FOLLOW UP INFORMATION RECEIVED ON MARCH 29, 2026, IT WAS FURTHER REPORTED THAT THERE WAS NO DIRECT PATIENT OR HEALTHCARE PROVIDER INJURY. THE SOURCE OF THE LEAK COULD NOT BE CLEARLY IDENTIFIED. THE REPORTER STATED THAT AFTER ENSURING THE DRAINAGE CAP WAS TWISTED CLOSED, APPROXIMATELY 1000 ML OF FLUID WAS COLLECTED, THE DEVICE WAS DISCONNECTED FROM THE PATIENT, THE ROLLER CLAMP WAS CLOSED, AND THE PLEURX BAG WAS DISCARDED INTO A GARBAGE BAG PLACED ON THE FLOOR. SHORTLY THEREAFTER, AN ESTIMATED 500 ML OF FLUID LEAKED ONTO THE FLOOR. DUE TO THE VOLUME OF FLUID AROUND THE BAG, THE EXACT SOURCE OF THE LEAK COULD NOT BE VISUALLY DETERMINED. AS THE DRAINAGE CAP AND ROLLER CLAMP HAD BEEN CONFIRMED CLOSED, THE LEAK WAS SUSPECTED TO HAVE ORIGINATED FROM THE BAG ITSELF OR POSSIBLY FROM THE CONNECTION BETWEEN THE BAG AND THE TUBING. THE CUSTOMER STATED THAT THEY HAD HEARD OF SEVERAL OTHER INSTANCES OF BAGS LEAKING IN THE PAST MONTH. DURING FOLLOW UP, THE CUSTOMER INDICATED THEY WERE NOT AWARE OF ANY PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848768 ↗
• MalfunctionApr 3, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER ON (B)(6) 2026, THAT THE PERITX DRAINAGE BAG WAS LEAKING DURING USE, DESPITE CONFIRMATION THAT BOTH THE DRAINAGE END AND THE CLAMP WERE SECURELY CLOSED. DURING FOLLOW UP INFORMATION RECEIVED ON MARCH 29, 2026, IT WAS FURTHER REPORTED THAT THERE WAS NO DIRECT PATIENT OR HEALTHCARE PROVIDER INJURY. THE SOURCE OF THE LEAK COULD NOT BE CLEARLY IDENTIFIED. THE REPORTER STATED THAT AFTER ENSURING THE DRAINAGE CAP WAS TWISTED CLOSED, APPROXIMATELY 1000 ML OF FLUID WAS COLLECTED, THE DEVICE WAS DISCONNECTED FROM THE PATIENT, THE ROLLER CLAMP WAS CLOSED, AND THE PLEURX BAG WAS DISCARDED INTO A GARBAGE BAG PLACED ON THE FLOOR. SHORTLY THEREAFTER, AN ESTIMATED 500 ML OF FLUID LEAKED ONTO THE FLOOR. DUE TO THE VOLUME OF FLUID AROUND THE BAG, THE EXACT SOURCE OF THE LEAK COULD NOT BE VISUALLY DETERMINED. AS THE DRAINAGE CAP AND ROLLER CLAMP HAD BEEN CONFIRMED CLOSED, THE LEAK WAS SUSPECTED TO HAVE ORIGINATED FROM THE BAG ITSELF OR POSSIBLY FROM THE CONNECTION BETWEEN THE BAG AND THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779862 ↗