Peristeen Plus 29142Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05701780235914), received between Mar 3, 2023 and Sep 14, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  This case concerns an 84-year old female patient who was enrolled in a bowel care program and had been trained on the irrigation procedure by a healthcare professional. During a follow-up contact, the patient reported that, after performing an irrigation procedure, the patient experienced bleeding and severe abdominal pain and was subsequently admitted to a hospital. According to the patient, a bowel perforation was diagnosed. While a direct causal relationship cannot be confirmed, the patient's report indicates a possible association with the irrigation procedure. The patient was unable to recall the number of pump strokes or the volume of water used during the irrigation but stated that the volume was not large. The patient reported routinely using Freka Glyss; however, Freka Glyss was not used on the day of the event, and only the irrigation procedure was performed. No additional information is currently available.

  Patient problems: Abdominal Pain; Bowel Perforation; Gastrointestinal Hemorrhage

  MAUDE report 50754244 ↗
• InjuryMar 3, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE CONCERNS A 23-YEAR-OLD MALE WHO HAS BEEN USING PERISTEEN TRANSANAL IRRIGATION FOR AN UNKNOWN PERIOD AND FOR AN UNKNOWN CONDITION. THE FOLLOWING INFORMATION IS AVAILABLE BY COMMUNICATION WITH THE FATHER OF THE USER: ON (B)(6) 2023, THE FATHER INSERTED THE PERISTEEN PLUS CATHETER (REGULAR SIZE) INTO THE ANAL CANAL OF THE USER. THE CATHETER WAS NOT CONNECTED TO THE TUBE AND THE CATHETER WAS INSERTED TOO FAR IN THE RECTUM AND COULD NOT BE RETRIEVED. THE FATHER WAS ADVISED TO SEEK MEDICAL ATTENTION AND WENT TO THE EMERGENCY UNIT WITH THE SON IN THE AFTERNOON ON THE SAME DAY. THE CATHETER WAS REMOVED UNDER ANESTHESIA WITHOUT ANY PROBLEMS (PRESUMABLE ENDOSCOPY). THE USER WAS NOT ADMITTED NOR PRESCRIBED ANY MEDICATION. IT WAS REPORTED THAT THE CATHETER HAD TRAVELLED 80 CM UP IN THE COLON NEAR THE LOCATION OF THE SPLEEN. NO ADDITIONAL HARMS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16477716 ↗