New Image 15603Recalls & reported problems
Hollister Incorporated · 2-Piece Ostomy Skin Barrier, Flextend · 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 00610075156030), received between Feb 16, 2022 and Feb 16, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
Device problems
- Fluid/Blood Leak1
- Product Quality Problem1
Patient problems
- Exposure to Body Fluids1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2022Fluid/Blood Leak; Product Quality Problem
HOLLISTER ILEOSTOMY PRODUCT; I HAVE AN ILEOSTOMY, THE RESULT OF SURGERY FOR COLON CANCER. I HAD TO CHANGE THE FLANGE (HOLLISTER MODEL 15603) IN THE MORNING, BUT THE ADHESIVE PORTION OF THE FLANGE BEGAN TO PEEL AWAY FROM MY SKIN THAT EVENING, SO IT STARTED TO LEAK. IN THE END I HAD TO CHANGE THE FLANGE AGAIN: THAT HAS NEVER HAPPENED BEFORE, AND I BELIEVE IT INDICATES A SERIOUS QUALITY PROBLEM WITH HOLLISTER. I HAVE HAD THE ILEOSTOMY FOR 26 YEARS AND IN THAT TIME I HAVE CHANGED THE FLANGE HUNDREDS OF TIMES. NEVER HAVE I EXPERIENCED SUCH A PROBLEM. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Exposure to Body Fluids
MAUDE report 13549602 ↗
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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