GENTLECATH GLIDERecalls & reported problems across all models
Convatec, Purchasing Department · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 572
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 0
We found 9 models of GENTLECATH GLIDE by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 572 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2017 and Sep 23, 2026 — classified as 28 injuries, 544 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (301 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GENTLECATH GLIDE problems
Device problems
- Tear, Rip or Hole in Device Packaging301
- Unsealed Device Packaging140
- Sharp Edges46
- Leak/Splash39
- Contamination /Decontamination Problem27
- Adverse Event Without Identified Device or Use Problem23
- Delivered as Unsterile Product10
- Difficult to Remove10
Patient problems
- No Clinical Signs, Symptoms or Conditions496
- Urinary Tract Infection27
- Hemorrhage/Blood Loss/Bleeding19
- Rash10
- Unspecified Tissue Injury9
- No Consequences Or Impact To Patient6
- Tissue Breakdown5
- No Patient Involvement3
GENTLECATH GLIDE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GENTLECATH GLIDE 421567Catheter, Urological342 reports
- GENTLECATH GLIDE 421566Catheter, Urological81 reports
- GENTLECATH GLIDE 421572Catheter, Urological64 reports
- GENTLECATH GLIDE 421569Catheter, Urological31 reports
- GENTLECATH GLIDE 421570Catheter, Urological19 reports
- GENTLECATH GLIDE 421565Catheter, Urological13 reports
- GENTLECATH GLIDE 421568Catheter, Urological12 reports
- GENTLECATH GLIDE 421571Catheter, Urological8 reports
- GENTLECATH GLIDE 421573Catheter, Urological2 reports
Recent GENTLECATH GLIDE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
End user reports she has a lot of bladder/ health concerns mentioning IC and overactive bladder and she constantly has the feeling of a UTI, constant burning and irritation is her normal due to her conditions stating she has even tried bladder installations that have not helped her condition in past. She said she last had a diagnosed UTI in July. Following the diagnosis and treatment of her UTI in July she was placed on Methenamine for UTI prevention which she said she has had 2 subsequent urine cultures which were negative. Her cultures were not done due to the bleeding event but due to just the overall feeling she always has a UTI. She does not take blood thinners but does have history of blood clots/pulmonary embolism in her past. She is planning to follow up with a Urogynecologist. No additional information is available. This eMDR is to address the UTI's with unknown lot and market unit.
Patient problems: Urinary Tract Infection
MAUDE report 50867782 ↗MalfunctionSep 22, 2026Entrapment of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853404 ↗MalfunctionSep 4, 2026Entrapment of Device
To date no additional patient or event details have been received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611912 ↗MalfunctionSep 4, 2026Entrapment of Device
To date no additional patient or event details have been received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611911 ↗MalfunctionApr 1, 2026Sharp Edges
END USER REPORTS "SOME OF THE GC GLIDES INCLUDED IN THE SAMPLE PACK FELT PARTICULARLY UNCOMFORTABLE, "STATING THERE WAS A SCRATCHING/PINCHING SENSATION 6 TO 8 INCHES INTO INSERTION OF CATHETER" HE SAID IT FELT LIKE AROUND THE EYELETS THERE WAS A "HANGNAIL ON THERE" WITH INSERTION. HE DID NOT FORCE THEM IN FURTHER WHEN HE FELT THIS AND REMOVED THEM. HE DID NOT EXPERIENCE ANY BLEEDING. NO HARM REPORTED. HE DID NOT EXAMINE THE CATHETERS AFTER REMOVAL TO SEE OR FEEL WITH HIS HAND IF THERE WERE ANY DEFORMITIES ON THE EYELETS OR ON THE CATHETER AS HE FELT WITH INSERTION. HE SAID HE HAS VERY CALLOUSED HANDS AND LIKELY WOULDN'T HAVE BEEN ABLE TO FEEL ANY SUBTLE DEFECTS ANYWAYS. HE DISCARDED THEM. HE WAS ALSO PREPPING THEM CORRECTLY AS WELL PRIOR TO USE." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755387 ↗MalfunctionApr 1, 2026Packaging Problem
END USER REPORTS SOME OF THE PACKAGING WASN¿T SEALED CORRECTLY SO WHEN THE WATER SACHET WAS POPPED IT WOULD LEAK. NO PHOTO WAS AVAILABLE. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR COVERS THE UNKNOWN QTY FROM THIS LOT #.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754271 ↗MalfunctionApr 1, 2026Sharp Edges
END USER REPORTS "SOME OF THE GC GLIDES INCLUDED IN THE SAMPLE PACK FELT PARTICULARLY UNCOMFORTABLE, "STATING THERE WAS A SCRATCHING/PINCHING SENSATION 6 TO 8 INCHES INTO INSERTION OF CATHETER" HE SAID IT FELT LIKE AROUND THE EYELETS THERE WAS A "HANGNAIL ON THERE" WITH INSERTION. HE DID NOT FORCE THEM IN FURTHER WHEN HE FELT THIS AND REMOVED THEM. HE DID NOT EXPERIENCE ANY BLEEDING. NO HARM REPORTED. HE DID NOT EXAMINE THE CATHETERS AFTER REMOVAL TO SEE OR FEEL WITH HIS HAND IF THERE WERE ANY DEFORMITIES ON THE EYELETS OR ON THE CATHETER AS HE FELT WITH INSERTION. HE SAID HE HAS VERY CALLOUSED HANDS AND LIKELY WOULDN'T HAVE BEEN ABLE TO FEEL ANY SUBTLE DEFECTS ANYWAYS. HE DISCARDED THEM. HE WAS ALSO PREPPING THEM CORRECTLY AS WELL PRIOR TO USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753133 ↗MalfunctionMar 12, 2026Unsealed Device Packaging
END USER REPORTS "ONE CATHETER SEALED IN THE SEAL". PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583393 ↗MalfunctionMar 12, 2026Sharp Edges
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24580763 ↗MalfunctionMar 9, 2026Packaging Problem
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547521 ↗MalfunctionMar 3, 2026Entrapment of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497852 ↗MalfunctionFeb 26, 2026Packaging Problem
END USER REPORTS THE PACKAGING OF THE GLIDE CATHETER SPLITS ON THE SIDE. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR COVERS THE UNKNOWN LOT NUMBERS AND UNKNOWN QUANTITY ASSOCIATED WITH THE REPORTED DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461901 ↗MalfunctionFeb 26, 2026Packaging Problem
END USER REPORTS THE PACKAGING OF THE GLIDE CATHETER SPLITS ON THE SIDE. THERE WAS NO HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24461897 ↗MalfunctionFeb 9, 2026Sharp Edges
END USER STATES "HE CAN FEEL A BURR NEAR THE EYELET FOR HIS GC GLIDE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291803 ↗MalfunctionFeb 9, 2026Sharp Edges
END USER STATES "HE CAN FEEL A BURR NEAR THE EYELET FOR HIS GC GLIDE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291802 ↗
Other Convatec, Purchasing Department products
- DUODERM9 models · 7,142 reports · 1 recall
- SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
- NATURA15 models · 5,161 reports
- CURE CATHETER25 models · 862 reports
- ESTEEM52 models · 200 reports · 7 recalls
- ACTIVELIFE21 models · 437 reports · 2 recalls
- GENTLECATH8 models · 430 reports
- ESTEEM SYNERGY9 models · 241 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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