GentleCathTM 508994Recalls & reported problems
Oasis Medikal Urunler Kimya Turizm Sanayi Ve Ticaret Anonim Sirketi · Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 10FR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455142620), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE PATIENT, SOME CATHETERS HAVE ROUGH EYELETS AND SHARP EDGES. THE PATIENT CLAIMS THE MECHANISM WITH HOW THE EYELETS ARE BEING PUNCHED OUT IN MANUFACTURING IS NOT WORKING CORRECTLY AND EYELETS ARE NOT BEING POLISHED WELL. THE CATHETERS WITH SHARP EDGES HAVE CAUSED BLEEDING IN HIM AS THEY PASS THROUGH HIS PROSTATE, BUT BLEEDING TYPICALLY STOPS QUICKLY WITHOUT INTERVENTION, AND AT HIS NEXT CATHETERIZATION (AFTER 3-4 HOURS) THE BLEEDING IS GONE. HE IS NOT ON BLOOD THINNERS AND DID NOT SEEK MEDICAL CARE FOR HIS BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19151269 ↗
Other CATHETER, STRAIGHT devices
- Magic3 Go Male Catheter with SureGrip 53814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall490 reports
- Magic3 Go Male Coude Catheter with SureGrip 50814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall3 deaths416 reports
- Magic3 Go™ Intermittent Urinary Catheter 51814C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall327 reports
- Magic3 Go Male Coude Catheter with SureGrip 50816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall239 reports
- Magic3 Go Male Catheter with SureGrip 53816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall164 reports
- Magic3 Go Male Catheter with SureGrip 53812GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall120 reports
- Magic3 Go™ Intermittent Urinary Catheter 51812C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall109 reports
- CURE CATHETER HM14Convatec, Purchasing Department · Catheter, Straight154 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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