MaxPlus, MaxGuard MP9238-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403237126), received between Sep 19, 2018 and Sep 19, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 16, 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.

• MalfunctionSep 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE INFUSION SET WAS ATTACHED TO THE PATIENT AND THE FLUIDS HAD LEAKED ONTO THE PATIENT¿S BED. CUSTOMARILY, THE "IV RESEAL" WAS ATTACHED TO A FLUSH SYRINGE OR CONNECTED BETWEEN THE IV (TYPICALLY #20GA) AND THE PRIMARY INFUSION TUBING WITHOUT A PUMP ATTACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7892217 ↗
• MalfunctionSep 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE INFUSION SET WAS ATTACHED TO THE PATIENT WHEN FLUIDS HAD LEAKED ONTO THE PATIENT¿S BED. CUSTOMARILY, THE "IV RESEAL" WAS ATTACHED TO A FLUSH SYRINGE OR CONNECTED BETWEEN THE IV (TYPICALLY #20GA) AND THE PRIMARY INFUSION TUBING WITHOUT A PUMP ATTACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891827 ↗
• MalfunctionSep 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE INFUSION SET WAS ATTACHED TO THE PATIENT AND THE FLUIDS HAD LEAKED ONTO THE PATIENT¿S BED. CUSTOMARILY, THE IV RESEAL WAS ATTACHED TO A FLUSH SYRINGE OR CONNECTED BETWEEN THE IV (TYPICALLY #20GA) AND THE PRIMARY INFUSION TUBING WITHOUT A PUMP ATTACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891799 ↗
• MalfunctionSep 19, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT AN INFUSION SET SEPARATED WHEN THE PATIENTS ARM WAS MOVED, THEN A LEAK WAS DETECTED. CUSTOMARILY, THE IV RESEAL WAS ATTACHED TO A FLUSH SYRINGE OR CONNECTED BETWEEN THE IV (TYPICALLY #20GA) AND THE PRIMARY INFUSION TUBING WITHOUT A PUMP ATTACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891798 ↗
• MalfunctionSep 19, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT AN INFUSION SET SEPARATED WHEN THE PATIENTS ARM WAS MOVED, THEN A LEAK WAS DETECTED. CUSTOMARILY, THE "IV RESEAL" WAS ATTACHED TO A FLUSH SYRINGE OR CONNECTED BETWEEN THE IV (TYPICALLY #20GA) AND THE PRIMARY INFUSION TUBING WITHOUT A PUMP ATTACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891768 ↗
• MalfunctionSep 19, 2018Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE CUSTOMER REPORTED THAT AN INFUSION SET SEPARATED RESULTING IN BLOOD LEAKING ONTO THE BED AND FLOOR. CUSTOMARILY, THE "IV RESEAL" WAS ATTACHED TO A FLUSH SYRINGE OR CONNECTED BETWEEN THE IV (TYPICALLY #20GA) AND THE PRIMARY INFUSION TUBING WITHOUT A PUMP ATTACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891763 ↗