Peristeen Plus 29152Recalls & reported problems
Coloplast A/S · Peristeen Plus Transanal irrigation / Peristeen Plus Transanal Irrigation. System without a catheter. 1 control unit; 1 water bag (incl. screw top); 2 straps; 1 tube. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932732642), received between Oct 11, 2023 and Oct 11, 2023 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bowel Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE CONCERNS A 70-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF A SPINAL CORD INJURY AT T1. DUE TO INCONTINENCE TAI WITH PERISTEEN WAS INITIATED APPROXIMATELY 4-5 YEARS AGO USING 800-1000 ML OF WATER, DAILY AND WITH 3 PUMPS OF THE BALLOON. THE PATIENTS USED AROUND 1.5 HOURS FOR THE PROCEDURE AND STILL EXPERIENCED WEEKLY PROBLEMS AND VARIED STOOL CONSISTENCY AND VARIED SIT TIME (FROM INSTANT RESULTS TO LONG PERIODS OF WAITING). ON (B)(6) 2023, THE PATIENT PERFORMED A TAI PROCEDURE WITH NORMAL INSERTION OF THE CATHETER AND AT LEAST 3 PUMPS OF THE BALLOON. THE BALLOON WAS NOT STAYING IN PLACE AND THERE WAS LEAKAGE, WHICH LED TO THE PATIENT USING HIS FINGERS TO HOLD OR REPOSITION THE BALLOON. THE PATIENT DID NOT EXPERIENCE PAIN (PROBABLY BECAUSE OF THE UNDERLYING CONDITION), BUT NOTICED BLOOD, WHICH HE WAS USED TO WITH IRRIGATIONS DUE TO HEMORRHOIDS. HOWEVER, THE BLEEDING CONTINUED, AND THE PATIENT CALLED A MD AND THE FOLLOWING DAY THE PATIENT WAS HOSPITALIZED. IT WAS REPORTED (NOT SPECIFIED HOW ASSESSED) THAT THE PATIENT HAD AN INTRAPERITONEAL RECTAL PERFORATION WITH LARGE HEMATOMA NEAR THE RECTOSIGMOID MESENTERY. THE PATIENT HAD SURGERY
Patient problems: Bowel Perforation
MAUDE report 17916408 ↗
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- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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