Nisus NPWT System CMPP-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851675007005), received between Apr 29, 2020 and Sep 12, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Battery 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  ON AUGUST 14, 2025, A CORK MEDICAL DISTRIBUTOR REPORTED A DEVICE FAILURE WITH THE DESCRIPTION "BURNED HOLE IN BACK OF DEVICE." COMMUNICATION WITH THE DISTRIBUTOR CONFIRMED THAT THERE WERE NO INJURIES SUSTAINED AND NO DAMAGE TO OTHER PROPERTY. THE DISTRIBUTOR INDICATED THAT THE FAILURE WAS ONLY NOTICED WHEN THE CAREGIVER PERFORMED A CANISTER CHANGE. AT THAT POINT, THE USE OF THE DEVICE WAS DISCONTINUED, AND THE DEVICE WAS RETURNED TO CORK MEDICAL FOR EVALUATION. CORK MEDICAL RECEIVED THE DEVICE ON AUGUST 18, 2025. UPON RECEIPT, CORK MEDICAL ENGINEERING STAFF REVIEWED THE DEVICE WITH QUALITY PERSONNEL AND OBSERVED THAT THE DEVICE APPEARED TO HAVE THERMAL DAMAGE TO THE BATTERY AND REAR HOUSING. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED DUE TO THE THERMAL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040148 ↗
• MalfunctionDec 29, 2020Battery Problem; Battery Problem

  A NISUS PUMP WAS RETURNED WITH A COMPLAINT ALLEGING THAT THE BATTERY MALFUNCTIONED CAUSING THE PUMP TO BE INOPERABLE. NO INJURIES OR HARM WERE REPORTED AS THE PUMP WAS DISCONNECTED FROM THE PATIENT. DUE TO THE STATE OF THE DEVICE, NO FUNCTIONAL TESTING WAS FEASBLE, BUT FURTHER VISUAL INSPECTION FOUND MELTING OF THE REAR HOUSING OCCURRED EXPOSING THE UNIT TO ATMOSPHERE. ANALYSIS OF THE DEVICE CONFIRMS THE FAULT WAS LIKELY THE RESULT OF A SHORT ON THE BATTERY CONTROL BOARD. THIS EVENT HAS BEEN REPORTED TO THE MANUFACTURER OF THE ASSOCIATED LITHIUM BATTERIES FOR FURTHER ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089833 ↗
• MalfunctionApr 29, 2020Battery Problem; Battery Problem

  A NISUS PUMP WAS RETURNED WITH A COMPLAINT ALLEGING THAT THE BATTERY WAS NO LONGER HOLDING A CHARGE AND WOULD NOT OPERATE FROM THE CHARGER CABLE AS INTENDED. NO INJURIES OR HARM WERE REPORTED. UPON INSPECTION, IT WAS DISCOVERED THAT THE BATTERY HAD EXPERIENCED A SHORT-CIRCUIT ON THE CONTROL BOARD, CAUSING THERMAL DAMAGE TO THE HOUSING INTERIOR. NO FAULT WAS FOUND WITH THE DEVICE OR ITS CIRCUITRY. THE NISUS UNIT FUNCTIONED AS DESIGNED, WHEN POWERED UTILIZING AN EXTERNAL POWER SOURCE. NO ELECTRICAL ANOMALIES OR FAULTS CAN BE CONFIRMED ASSOCIATED WITH THE NISUS DEVICE. ANALYSIS OF THE EVENT BY THE SUPPLIER OF THE ASSOCIATED LITHIUM BATTERY CONFIRMS THE FAULT WAS LIKELY THE RESULT OF A SHORT ON THE BATTERY CONTROL BOARD. THIS EVENT HAS BEEN REPORTED TO THE MANUFACTURER OF THE ASSOCIATED LITHIUM BATTERIES FOR FURTHER ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009035 ↗
• MalfunctionApr 29, 2020Battery Problem; Battery Problem

  A NISUS PUMP WAS RETURNED WITH A COMPLAINT ALLEGING THAT THE BATTERY WAS NO LONGER HOLDING A CHARGE BUT WOULD OPERATE FROM THE CHARGER CABLE AS INTENDED. NO INJURIES OR HARM WERE REPORTED. UPON INSPECTION, IT WAS DISCOVERED THAT THE BATTERY HAD EXPERIENCED A SHORT-CIRCUIT ON THE CONTROL BOARD, CAUSING THERMAL DAMAGE TO THE HOUSING INTERIOR. NO FAULT WAS FOUND WITH THE DEVICE OR ITS CIRCUITRY. THE NISUS UNIT FUNCTIONED AS DESIGNED, WHEN POWERED UTILIZING AN EXTERNAL POWER SOURCE. NO ELECTRICAL ANOMALIES OR FAULTS CAN BE CONFIRMED ASSOCIATED WITH THE NISUS DEVICE. ANALYSIS OF THE EVENT BY THE SUPPLIER OF THE ASSOCIATED LITHIUM BATTERY CONFIRMS THE FAULT WAS LIKELY THE RESULT OF A SHORT ON THE BATTERY CONTROL BOARD. THIS EVENT HAS BEEN REPORTED TO THE MANUFACTURER OF THE ASSOCIATED LITHIUM BATTERIES FOR FURTHER ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10009023 ↗
• MalfunctionApr 29, 2020Battery Problem; Battery Problem

  A NISUS PUMP WAS RETURNED WITH A COMPLAINT ALLEGING THAT THE BATTERY WAS NO LONGER HOLDING A CHARGE BUT WOULD OPERATE FROM THE CHARGER CABLE AS INTENDED. NO INJURIES OR HARM WERE REPORTED. UPON INSPECTION, IT WAS DISCOVERED THAT THE BATTERY HAD EXPERIENCED A SHORT-CIRCUIT ON THE CONTROL BOARD, CAUSING THERMAL DAMAGE TO THE HOUSING INTERIOR. NO FAULT WAS FOUND WITH THE DEVICE OR ITS CIRCUITRY. THE NISUS UNIT FUNCTIONED AS DESIGNED, WHEN POWERED UTILIZING AN EXTERNAL POWER SOURCE. NO ELECTRICAL ANOMALIES OR FAULTS CAN BE CONFIRMED ASSOCIATED WITH THE NISUS DEVICE. ANALYSIS OF THE EVENT BY THE SUPPLIER OF THE ASSOCIATED LITHIUM BATTERY CONFIRMS THE FAULT WAS LIKELY THE RESULT OF A SHORT ON THE BATTERY CONTROL BOARD. THIS EVENT HAS BEEN REPORTED TO THE MANUFACTURER OF THE ASSOCIATED LITHIUM BATTERIES FOR FURTHER ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009016 ↗