Irrisept Antimicrobial Wound Lavage ISEPT-450-USARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10842351190002), received between Feb 5, 2021 and Apr 2, 2025 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC SURGERY WHERE IRRISEPT WAS USED FOR IRRIGATION. ACCORDING TO THE EVENT INFORMATION PROVIDED, THE PRODUCT WAS USED IN THE PROCEDURE AND DUE TO THE SURGICAL CONDITIONS PRESENT, THE FLUID WAS BELIEVED TO HAVE COME INTO CONTACT WITH THE PATIENT INTRAVASCULARLY. THE PATIENT PRESENTED INCREASED VALUES OF LACTIC ACID WHICH WAS TREATED AND RESOLVED. IT WAS ALSO STATED THAT THESE ISSUES DATE BACK TO 2022. NO ADDITIONAL PATIENT HARM OR INTERVENTION WAS REQUIRED OR REPORTED. NO OTHER INFORMATION ABOUT THE PATIENT WAS PROVIDED. IRRIMAX ADVISED THAT IRRISEPT SHOULD NOT BE USED WHEN POTENTIAL FOR INTRAVASCULAR INJECTION IS POSSIBLE AS THE PRODUCT LABELING STATES "NOT FOR INJECTION".

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 21756123 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION AVAILABLE, ON APPROXIMATELY (B)(6) 2024 AND AFTER HAVING BEEN ASSESSED FOR OVER A DECADE, THE INVOLVED PATIENT UNDERWENT MICROVASCULAR DECOMPRESSION FOR TRIGEMINAL NEURALGIA. THE PRODUCT WAS USED FOR IRRIGATION. POST-PROCEDURE, THE PATIENT DEVELOPED HYDROCEPHALUS AND REQUIRED A VP SHUNT. BASED UPON THE INFORMATION PROVIDED, SYMPTOM MANAGEMENT IS BEING ACHIEVED, AND THE SHUNT SHOULD BE ABLE TO BE TURNED OFF.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21469171 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION AVAILABLE, ON APPROXIMATELY (B)(6) 2024 AND AFTER HAVING BEEN ASSESSED FOR OVER A DECADE, THE INVOLVED PATIENT UNDERWENT A PROCEDURE FOR MENINGIOMA. PROCEDURE CONSISTED OF EMBOLIZATION OF THE MENINGES TO DECREASE BLEEDING. THE PRODUCT WAS USED FOR IRRIGATION. POST-PROCEDURE, THE PATIENT DEVELOPED HYDROCEPHALUS AND REQUIRED A VP SHUNT. BASED UPON THE INFORMATION PROVIDED, SYMPTOM MANAGEMENT IS BEING ACHIEVED, AND THE SHUNT SHOULD BE ABLE TO BE TURNED OFF.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21468561 ↗
• MalfunctionMar 7, 2023Fluid/Blood Leak; Device Difficult to Setup or Prepare

  BOTTLE LEAKING PRIOR TO OPENING, THIS WAS FOUND PRIOR TO OPENING, BOTTLE NOT USED OR PRESENTED TO STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495009 ↗
• MalfunctionSep 8, 2021Contamination

  CIRCULATOR OPENED IRRISEPT PACKAGE ASEPTICALLY TO SCRUB TECH. SCRUB TECH OPENED OUTER WRAP AND HAIR WAS NOTED ON THE PROTECTIVE RING. SCRUB TECH PASSED IT BACK TO CIRCULATOR AND CHANGED OUTER GLOVES. HAIR SECURED TO PROTECTIVE RING WITH TAPE WHERE FOUND TO PREVENT LOSS. PACKAGING AND PRODUCT WITH HAIR SAVED FOR OR QUALITY.

  Patient problems: Insufficient Information

  MAUDE report 12438312 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE (INTERNAL DEHISCENCE OF ARTHROTOMY REPAIR).

  Patient problems: Impaired Healing; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy

  MAUDE report 11475186 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE PHYSICIAN, IRRISEPT WAS USED IN A RE-OPERATION WITHIN 3-4 DAYS INVOLVING THE ABDOMEN AND THE NUMBER OF ADHESIONS "WAS NOT NORMAL."

  Patient problems: Adhesion(s)

  MAUDE report 11440317 ↗
• InjuryFeb 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  LEFT KNEE (INTERNAL DEHISCENCE) OF ARTHROTOMY REPAIR.

  Patient problems: Impaired Healing; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy

  MAUDE report 11367204 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE PHYSICIAN, THE WOUNDS OF SEVERAL PATIENTS APPEARED INFLAMED ALONG THE INCISIONAL LINE AND WERE RED, SOMEWHAT RAISED, AND HAD SMALL ANGIOMATOUS TYPE VESSELS GROWING FROM THE WOUND OUTWARD.

  Patient problems: Inflammation; Skin Inflammation/ Irritation

  MAUDE report 11309374 ↗
• InjuryFeb 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT KNEE INTERNAL DEHISCENCE OF ARTHROTOMY REPAIR.

  Patient problems: Damage to Ligament(s); Impaired Healing; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy

  MAUDE report 11287802 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem

  LEFT KNEE INTERNAL DEHISCENCE OF ARTHROTOMY REPAIR.

  Patient problems: Impaired Healing; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy

  MAUDE report 11287797 ↗
• InjuryFeb 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD VASTUS MEDIALIS OBLIQUUS (VMO) FAILURE 6 TO 12 WEEKS POST-OPERATIVELY. FOLLOW-UP OPERATION WAS CONDUCTED TO REPAIR QUADRICEPS.

  Patient problems: Impaired Healing; Joint Dislocation; Loss of Range of Motion; Muscle Weakness/Atrophy

  MAUDE report 11287796 ↗