n.a. 031524-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048438006337), received between Mar 21, 2024 and Mar 22, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT TWO USED CASSETTE HOSE SETS FROM TWO DIFFERENT BATCHES WERE LEAKING AT THE PRESSURE DIAPHRAGM AFTER INSERTION INTO THE ENDOMAT SELECT UP210 PUMP. THE RINSING FLUID ESCAPED VIA THE DEFECTIVE MEMBRANE AFTER THE PUMP WAS STARTED UP AND FLOODED THE EQUIPMENT TRAILER WITH THE EQUIPMENT UNDERNEATH. NO HARM TO PATIENT, USER OR THIRD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960726 ↗
• MalfunctionMar 22, 2024Leak/Splash; Positioning Problem; Leak/Splash; Positioning Problem

  IT WAS REPORTED THAT TWO USED CASSETTE HOSE SETS FROM TWO DIFFERENT BATCHES WERE LEAKING AT THE PRESSURE DIAPHRAGM AFTER INSERTION INTO THE ENDOMAT SELECT UP210 PUMP. THE RINSING FLUID ESCAPED VIA THE DEFECTIVE MEMBRANE AFTER THE PUMP WAS STARTED UP AND FLOODED THE EQUIPMENT TRAILER WITH THE EQUIPMENT UNDERNEATH. NO HARM TO PATIENT, USER OR THIRD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960720 ↗
• MalfunctionMar 21, 2024Leak/Splash; Positioning Problem; Leak/Splash; Positioning Problem

  IT WAS REPORTED THAT TWO USED CASSETTE HOSE SETS FROM TWO DIFFERENT BATCHES WERE LEAKING AT THE PRESSURE DIAPHRAGM AFTER INSERTION INTO THE ENDOMAT SELECT UP210 PUMP. THE RINSING FLUID ESCAPED VIA THE DEFECTIVE MEMBRANE AFTER THE PUMP WAS STARTED UP AND FLOODED THE EQUIPMENT TRAILER WITH THE EQUIPMENT UNDERNEATH. NO HARM TO PATIENT, USER OR THIRD REPORTED. THE RISK IS COVERED IN THE RELATED RISK FILE (SAP-ID: (B)(6) ; RISK-ID: 1.1.05; SEVERITY-LEVEL: 4 (HARM: ELECTRIC SHOCK); PROBABILITY-LEVEL: 1 (IMPROBABLE)). IN ADDITION, NO EVENT (TIMEFRAME: BETWEEN 2022-03-05 AND 2024-03-19) THAT COULD BE CONSIDERED AS SIMILAR TO THIS ONE AND CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY COULD BE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952063 ↗
• InjuryMar 21, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT TWO USED CASSETTE HOSE SETS FROM TWO DIFFERENT BATCHES WERE LEAKING AT THE PRESSURE DIAPHRAGM AFTER INSERTION INTO THE ENDOMAT SELECT UP210 PUMP. THE RINSING FLUID ESCAPED VIA THE DEFECTIVE MEMBRANE AFTER THE PUMP WAS STARTED UP AND FLOODED THE EQUIPMENT TRAILER WITH THE EQUIPMENT UNDERNEATH. NO HARM TO PATIENT, USER OR THIRD REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952059 ↗