New Image 18003Recalls & reported problems
Hollister Incorporated · 2-Piece Drainable Ostomy Pouch · Class 1
All models of New Image (19)
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 00610075113958), received between Oct 23, 2025 and Oct 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Open or Close” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT AN END USER EXPERIENCED EFFLUENT LEAKAGE WHEN THE LOCK N ROLL CLOSURE OF THE HOLLISTER NEW IMAGE DRAINABLE POUCH UNROLLED. IT WAS REPORTED THAT THE END USER WEARS DEPENDS, WHICH ALSO COVERS THE POUCH, AND THE POUCH HAS BEEN OPENING, RESULTING IN CONTENTS LEAKING OUT INTO THE DEPENDS. IT WAS FURTHER REPORTED THAT THE LEAKAGE INTO HER DEPENDS ON LED TO A URINARY TRACT INFECTION (UTI), FOR WHICH SHE REQUIRED ANTIBIOTIC TREATMENT.
Patient problems: Urinary Tract Infection
MAUDE report 23366856 ↗
Other COLLECTOR, OSTOMY devices
- New Image 11704Hollister Incorporated · COLLECTOR, OSTOMY4 reports
- New Image 14803Hollister Incorporated · COLLECTOR, OSTOMY3 reports
- New Image 11504Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 14603Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 11703Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 11203Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8331Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8512Hollister Incorporated · COLLECTOR, OSTOMY1 report
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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