Neptune 0703001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 07613327116656), received between Jun 26, 2018 and Apr 3, 2026 — classified as 2 deaths, 4 injuries, 179 malfunctions.

The most frequently reported specific device problem is “Inadequate Filtration Process” (130 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 25 most recent of 185 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Use of Device Problem

  IT WAS REPORTED THAT THE NEPTUNE WAS MISTAKENLY CONNECTED TO A BRAIN DRAIN FOR 2-10 MINUTES, WHILE ON A LOW SUCTION SETTING. THE PATIENT SUFFERED A SEIZURE POST-OP IN PACU, WHICH REQUIRED NO MEDICAL INTERVENTION. IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF NEUROLOGICAL ISSUES; HOWEVER, NO HISTORY OF SEIZURES. IT IS UNKNOWN IF THE SEIZURE WAS A RESULT OF THE USER ERROR.

  Patient problems: Convulsion/Seizure

  MAUDE report 24777245 ↗
• DeathSep 13, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED BY THE SALES REP THAT DURING SURGERY, THE NEPTUNE 3 ROVER WAS CONNECTED TO THE ATRIUM OASIS DRY SUCTION WATER SEAL CHEST DRAIN. UPON CONNECTION, THE SURGEON REQUESTED SUCTION ON THE NEPTUNE BE INCREASED, WHICH IS NOT ADVISED PER THE IFU (SEE ADDITIONAL MFG NARRATIVE FOR DETAILS). IT WAS REPORTED THAT THE PATIENT PASSED AWAY POST-OP AND THAT THE PATIENT WAS UNHEALTHY PRIOR TO THE PROCEDURE. THERE WERE NO ALLEGED MALFUNCTIONS OF THE ROVER DURING THE PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20212283 ↗
• InjuryAug 22, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL ACDF PROCEDURE, IN WHICH A NEPTUNE 3 WASTE MANAGEMENT SYSTEM WAS IN USE. IT WAS FURTHER REPORTED THAT THE SURGEON MAY HAVE USED THE NEPTUNE TO QUANTIFY THE PATIENT'S BLOOD LOSS. IT WAS REPORTED THAT AN OUTCOME OF THE SURGERY WAS SEVERE SPINAL CORD INJURY. THE NEPTUNE 3 WASTE MANAGEMENT SYSTEM IS NOT INDICATED FOR THE USE OF QUANTIFYING BLOOD LOSS.

  Patient problems: Paralysis

  MAUDE report 20033351 ↗
• InjuryDec 19, 2022Increase in Suction; Increase in Suction

  PER THE CUSTOMER, IT WAS REPORTED THAT A PATIENT'S BLADDER WAS "NICKED" DURING A SURGERY. PER THE CUSTOMER DURING THE PROCEDURE "THERE WAS PERHAPS TO MUCH SUCTION," FROM THE NEPTUNE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: Laceration(s)

  MAUDE report 16003728 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UPPER LOBECTOMY PROCEDURE THE PATIENT DEVELOPED AN AIR LEAK THAT NEEDED TO BE SEALED. THE REPORTED EVENT DID NOT INDICATE THE DEVICE MALFUNCTIONED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pneumothorax

  MAUDE report 15585882 ↗
• MalfunctionDec 17, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026442 ↗
• MalfunctionDec 15, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012388 ↗
• MalfunctionDec 14, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003677 ↗
• MalfunctionDec 13, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12985243 ↗
• MalfunctionDec 10, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975305 ↗
• MalfunctionDec 10, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975259 ↗
• MalfunctionNov 30, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12893758 ↗
• MalfunctionNov 29, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887524 ↗
• MalfunctionNov 29, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887446 ↗
• MalfunctionNov 29, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12884086 ↗
• MalfunctionNov 22, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853774 ↗
• MalfunctionNov 22, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853768 ↗
• MalfunctionNov 22, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853660 ↗
• MalfunctionNov 19, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845151 ↗
• MalfunctionNov 17, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830285 ↗
• MalfunctionNov 15, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814352 ↗
• MalfunctionNov 15, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813867 ↗
• MalfunctionNov 8, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12773389 ↗
• MalfunctionNov 8, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12772651 ↗
• MalfunctionNov 4, 2021Inadequate Filtration Process; Inadequate Filtration Process

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE SMOKE EVACUATOR FAILED DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751016 ↗