Irrisept Irrisept-403Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10842351100032), received between Jul 20, 2017 and Sep 10, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2018Off-Label Use; Off-Label Use

  PATIENT EXPERIENCED EKG CHANGE.

  Patient problems: Arrhythmia; Non specific EKG/ECG Changes

  MAUDE report 7861330 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED THAT PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY (TKA) 22 YEARS AGO. PHYSICIAN REPORTED THAT PATIENT UNDERWENT A REVISION FOR THE LEFT TKA FOR IMPLANT LOOSENING ON (B)(6) 2017. IRRISEPT WAS USED. PHYSICIAN REPORTED THAT PATIENT UNDERWENT A TKA REVISION INCLUDING POLY EXCHANGE ON (B)(6) 2017 TO ADDRESS SWELLING. IRRISEPT WAS USED AND THE PHYSICIAN REPORTED THAT THERE WAS NO INFECTION. PHYSICIAN REPORTED THAT PATIENT UNDERWENT ANOTHER TKA REVISION WITH SYNOVECTOMY ON (B)(6) 2017 INCLUDING POLY EXCHANGE AND THAT PATIENT HAD A REACTION TO CHRLORAPREP (CHLORHEXIDINE) SKIN PREP PRIOR TO INCISION. PHYSICIAN REPORTED IRRISEPT WAS USED FOR IRRIGATION. PHYSICIAN REPORTED THAT PATIENT RECEIVED STANDARD TREATMENT WITH ANTIBIOTICS 24 HOURS POST-OPERATIVELY. PHYSICIAN REPORTED PATIENT UNDERWENT LEFT KNEE SCOPE WITH SYNOVECTOMY ON (B)(6) 2017 TO ADDRESS SWELLING AND PAIN. PHYSICIAN REPORTED THAT PATIENT WAS PREPPED WITH POVIDONE IODINE, THAT IRRISEPT WAS NOT USED, AND THAT THERE WERE NO SIGNS OF INFECTION. PHYSICIAN REPORTED THAT PATIENT LIKELY DEVELOPED HYPERSENSITIVITY TO CHG IN ALL FORMS AND CONCENTRATIONS.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 7096620 ↗
• InjuryJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED THAT THE USE OF IRRISEPT DURING AN INDIRECT BIOPSY POSSIBLY COULD HAVE CAUSED SEIZURE(S) AND/OR STROKE(S) IN A PATIENT WITH MOYAMOYA DISEASE. ACCORDING TO NIH, MOYAMOYA DISEASE IS A PROGRESSIVE, OCCLUSIVE DISEASE OF THE CEREBRAL VASCULATURE INVOLVING THE CAROTID ARTERY IN THE SKULL. MOYAMOYA MAY CAUSE TRANSIENT ISCHEMIC ATTACKS, STROKES, ANEURYSMS OR BLEEDING IN THE BRAIN. PHYSICIAN REPORTED THAT THE USE OF IRRISEPT DURING THE INDIRECT BIOPSY OF THE PATIENT WITH MOYAMOYA DISEASE AND THE SEIZURE(S) AND/OR STROKE(S) WERE LIKELY NOT LINKED.

  Patient problems: Seizures; Transient Ischemic Attack

  MAUDE report 6730321 ↗