GentleCath Hydrophilic 508996Recalls & reported problems
Wellspect AB · Hydrophilic Intermittent Urinary Catheter With Water Sachet Male 16'' 14FR · Class 2
Data updated Oct 18, 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 07333387031699), received between Oct 23, 2025 and Oct 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
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.
MalfunctionOct 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
AN ADVERSE EVENT OCCURED IN US WHERE A PATIENT REPORTED HAVING HAD A TOTAL OF 4 UTI'S (URINARY TRACT INFECTIONS) IN RECENT YEARS AFTER STARTING TO USE THE GENTLECATH HYDROPHILIC CATHETER. THE RECENT LAST TWO UTIS WERE ON JULY 13 AND DIAGNOSED AT IMMEDIATE CARE AND GIVEN AN ANTIBIOTIC COURSE (5 DAYS). A WEEK AFTER HE HAD FINALIZED THE 5-DAY COURSE HIS SYMPTOMS RETURNED (DIDN'T FEEL WELL). HE DID A REFILL OF A PREVIOUS ANTIBIOTIC TREATMENT FOR ABOUT ONE WEEK (7 DAYS) THAT HE HAD RECEIVED FROM HIS UROLOGIST. PATIENT STATES THAT HE WASN'T 100% BETTER AT THE CONCLUSION OF THAT TREATMENT COURSE AND WENT TO SEE HIS DOCTOR AS HIS URINE WAS MALODOROUS AND CLOUDY. HE DID A URINE SAMPLE BUT DID NOT KNOW RESULTS. HIS UROLOGIST DID NOT PRESCRIBE HIM ANY OTHER ADDITIONAL ANTIBIOTIC TREATMENTS, AND HE IS NOW FEELING MUCH BETTER. PATIENT DESCRIBES THAT HE HAS NOTICED THAT THE COATING ON CATHETERS SEEM TO BE STICKING TO SILVER WATER SACHET AND/OR PACKAGING (PRIOR TO ACTIVATION). HE STATES THAT THEY ARE EASY TO "YANK THEM OUT" AND THEY STILL FEEL OK TO USE. PATIENT STATES THAT AFTER HE HAS USED THEM, HE GETS UTIS SHORTLY AFTER AND SUSPECTS A POSSIBLE CORRELATION. THE PATIENT IS AN ACTIVE 80-YEAR-OLD
Patient problems: Urinary Tract Infection
MAUDE report 23368159 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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