RAW MATERIAL 30MRecalls & reported problems
Djo, LLC · VENAPRO SYSTEM · Class 2
Quick summary
This is a DJO Venapro system sleeve used for limb compression therapy. The 52 reports mostly describe the pump or sleeve overheating during treatment, sometimes shutting off or charging poorly, with no patient harm reported. There are no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00190446273288), received between May 31, 2019 and Mar 16, 2020 — classified as 52 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (52 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
Device problems
- Overheating of Device52
Patient problems
- No Known Impact Or Consequence To Patient27
- No Consequences Or Impact To Patient15
- No Patient Involvement9
- Discomfort1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE "LEFT PUMP INFLATES, NOT CHARGING WELL [AND] HEATING UP". THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9834864 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE "PUMP GOT HOT AND TURNED OFF LAST NIGHT WHEN IT WAS PLUGGED IN". THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9717630 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716553 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716545 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716544 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716543 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716542 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716541 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716540 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716539 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716538 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716537 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716535 ↗MalfunctionFeb 17, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE VENAPRO SYSTEM WAS OVERHEATING DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716534 ↗MalfunctionDec 30, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE UNIT BECAME TOO HOT WHILE CHARGING. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9529962 ↗MalfunctionDec 30, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE UNIT BECAME TOO HOT WHILE CHARGING. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9529956 ↗MalfunctionDec 30, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE UNIT BECAME TOO HOT WHILE CHARGING. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9529955 ↗MalfunctionDec 23, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE "RIGHT PUMP GOT HOT AND IS BLUE ALARMING" DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9510511 ↗MalfunctionDec 6, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BATTERY PACKS WERE OVERHEATING. THERE WAS REPORTEDLY NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9425657 ↗MalfunctionDec 6, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BATTERY PACKS WERE OVERHEATING. THERE WAS REPORTEDLY NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9425645 ↗MalfunctionDec 6, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BATTERY PACKS WERE OVERHEATING. THERE WAS REPORTEDLY NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9425641 ↗MalfunctionDec 6, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BATTERY PACKS WERE OVERHEATING. THERE WAS REPORTEDLY NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9425636 ↗MalfunctionDec 6, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BATTERY PACKS WERE OVERHEATING. THERE WAS REPORTEDLY NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9425627 ↗MalfunctionDec 6, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BATTERY PACKS WERE OVERHEATING. THERE WAS REPORTEDLY NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9425589 ↗MalfunctionDec 6, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE BATTERY PACKS WERE OVERHEATING. THERE WAS REPORTEDLY NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9425561 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.