GENTLECATHRecalls & reported problems across all models
Convatec, Purchasing Department · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 430
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 8 models of GENTLECATH by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 430 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2023 and Sep 29, 2026 — classified as 11 injuries, 419 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (391 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 problems
Device problems
- Device Misassembled During Manufacturing /Shipping391
- Sharp Edges24
- Adverse Event Without Identified Device or Use Problem7
- Device Handling Problem4
- Entrapment of Device2
- Off-Label Use2
- Contamination /Decontamination Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions388
- Hemorrhage/Blood Loss/Bleeding27
- Urinary Tract Infection11
- Discomfort4
- Pain1
- Unspecified Tissue Injury1
GENTLECATH models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GENTLECATH 421911Catheter, Urethral234 reports
- GENTLECATH 421910Catheter, Urethral122 reports
- GENTLECATH 421909Catheter, Urethral66 reports
- GENTLECATH 501023Catheter, Urological2 reports
- GENTLECATH 510601Catheter, straight2 reports
- GENTLECATH 510602Catheter, straight2 reports
- GENTLECATH 501021Catheter, Urological1 report
- GENTLECATH 501022Catheter, Urological1 report
Recent GENTLECATH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Unsealed Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933724 ↗MalfunctionSep 23, 2026Sharp Edges
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873332 ↗MalfunctionSep 23, 2026Sharp Edges
It was reported the catheters were "stuck with the package as if they were glued. As a result, those catheters had an inch length of rough surface. In spite of the rough surface, I managed to use them but it was not comfortable to insert it into the urethra because of the rough surface."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873331 ↗MalfunctionSep 23, 2026Sharp Edges
End user reports possible structural irregularity with rough tip. Reports ¿some of the products did feel rough at the tip when trying to insert. The curve of the tip seemed to be different or even the size of the tube, it is not a difference you can see.¿ No photo available. There was no harm reported. No further information obtained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867484 ↗MalfunctionSep 22, 2026Entrapment of Device
It was reported "catheters improperly stuck in individual packaging's heat seal."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857968 ↗MalfunctionSep 22, 2026Entrapment of Device
It was reported "catheters improperly stuck in individual packaging's heat seals. " No lot number provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857818 ↗MalfunctionJul 20, 2026Device Misassembled During Manufacturing /Shipping
To date no additional patient or event details have been received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882004 ↗MalfunctionJul 20, 2026Device Misassembled During Manufacturing /Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25881832 ↗MalfunctionJul 20, 2026Device Misassembled During Manufacturing /Shipping
To date no additional patient or event details have been received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25881830 ↗MalfunctionJul 20, 2026Sharp Edges
Patient problems: Unspecified Tissue Injury
MAUDE report 25877086 ↗MalfunctionApr 27, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS, UNKNOWN QTY "ALMOST EVERYONE" IN 1 MU BOX, THE COUDE TIP AND NOTCH ON FUNNEL NOT ALIGNED CAUSING DISCOMFORT AND HAD BLEEDING WITH USE. CONSUMER HAS SELF CATH'D FOR THE PAST 6 MONTHS, OFF AND ON, WITH THIS PRODUCT. HE STATES HE HAS HAD 6 TOTAL SURGERIES FOR URETHRAL SCAR TISSUE AND TURP PROCEDURES IN HIS PAST. HIS MOST RECENT SURGERIES WERE IN OCTOBER OF LAST YEAR AND THIS YEAR ON (B)(6). HE STARTED CIC LAST YEAR AFTER HIS OCTOBER PROCEDURE AND HE WAS ADVISED TO START TO SELF -CATH ONCE EVERY DAY FOR A MONTH FOLLOWING THE PROCEDURE AND TAPERING DOWN FOR THE NEXT 2 MONTHS UNTIL STOPPING THE NEED TO CATH. HIS SCAR TISSUE RETURNED BADLY THIS YEAR AND NOW AFTER HIS MOST RECENT SURGERY IN FEB, HE HAS BEEN ADVISED BY HIS UROLOGIST TO CATH AT LEAST ONCE A DAY TO DRAIN BLADDER BUT ALSO TO KEEP SCAR TISSUE DILATED AND OPEN. HE NOTES THAT IN HIS RECENT BOX ALMOST EVERY CATHETER IN THE BOX WAS MISALIGNED BY ABOUT 45 DEGREES. HE SAID IF YOU LOOK AT THE LINE ON THE NOTCH ON THE FUNNEL ON TOP, THE COUDE TIP IS POINTING TO THE LEFT ABOUT 45 DEGREES. HE SAID PASSING THESE WITH MISALIGNMENT CAN CAUSE DISCOMFORT AND HE DID HAVE SOME BLEEDING THIS WEEK WITH USE OF THESE DAILY, NOTING
Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding
MAUDE report 25008554 ↗MalfunctionApr 21, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS UNKNOWN QTY, UNKNOWN MUS, UNKNOWN LOTS IN PAST MANY OF WHICH THE GUIDE NOTCH ON FUNNEL WAS NOT PERFECTLY ALIGNED WITH THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS AND UNKNOWN MARKET UNITS ASSOCIATED WITH THE DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943139 ↗MalfunctionApr 17, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS MANY OF THE GUIDE NOTCH ON FUNNEL NOT PERFECTLY ALIGNED WITH THE COUDE TIP. HE STATES IN THE PAST HALF A YEAR HE HAS USED THIS PARTICULAR CATHETER, HE HAS NOTICED MAYBE ONE OR 2 NOT ALIGNED IN A BOX AND NEVER SAID ANYTHING. HE SPOKE UP BECAUSE IN THIS ORDER NEARLY EVERY SINGLE CATHETER FROM THE FIRST BOX HE USED UP WAS LIKE THIS AND NOW HE IS ON BOXES 2 AND 3 AND SAID THE MAJORITY ARE LIKE THIS AS WELL. HE REPORTS THE TIP AND THE NOTCH ON THE FUNNEL ARE NOT PERFECTLY ALIGNED. HE SAID IT IS OFF BY ABOUT 15 DEGREES. HE SAID AS AN EXAMPLE IF THE GUIDE IS AT 12 O CLOCK THE COUDE TIP IS POINTING AT 11:45 ON A CLOCK. NO PHOTO AVAILABLE. THERE WAS NO HARM. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH UNKNOWN LOT NUMBERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912653 ↗MalfunctionApr 17, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS MANY OF THE GUIDE NOTCH ON FUNNEL NOT PERFECTLY ALIGNED WITH THE COUDE TIP. HE STATES IN THE PAST HALF A YEAR HE HAS USED THIS PARTICULAR CATHETER, HE HAS NOTICED MAYBE ONE OR 2 NOT ALIGNED IN A BOX AND NEVER SAID ANYTHING. HE SPOKE UP BECAUSE IN THIS ORDER NEARLY EVERY SINGLE CATHETER FROM THE FIRST BOX HE USED UP WAS LIKE THIS AND NOW HE IS ON BOXES 2 AND 3 AND SAID THE MAJORITY ARE LIKE THIS AS WELL. HE REPORTS THE TIP AND THE NOTCH ON THE FUNNEL ARE NOT PERFECTLY ALIGNED. HE SAID IT IS OFF BY ABOUT 15 DEGREES. HE SAID AS AN EXAMPLE IF THE GUIDE IS AT 12 O CLOCK THE COUDE TIP IS POINTING AT 11:45 ON A CLOCK. NO PHOTO AVAILABLE. THERE WAS NO HARM. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THIS LOT#.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912651 ↗InjuryApr 8, 2026Device Handling Problem
END USER STATES SHE "WAS GIVEN SAMPLES OF OUR (B)(6) FR AND SHOWN HOW TO CIC AT UROLOGISTS OFFICE AND ADVISED PERFORMING CIC ONCE A DAY, AND AT NIGHT BEFORE BED DUE TO URINARY RETENTION, AS SHE HAS BEEN HAVING A WEAK STREAM FOR A WHILE NOW ESPECIALLY AT NIGHT. SHE SAID PREVIOUSLY IN HER LIFETIME (BEFORE EVEN STARTING CIC) SHE HAS HAD AROUND "5 OR SO" UTIS. SINCE SHE JUST STARTED CIC, THIS IS THE FIRST TIME SHE GOT A UTI WHICH STARTED JUST A FEW DAYS AFTER STARTING CIC. SHE REALLY ISN'T SURE WHERE THE UTI CAME FROM. SHE SAID AT HOME SHE STRUGGLED WITH FINDING THE RIGHT SPOT TO GET IT IN HER URETHRA WHEN SHE FIRST ATTEMPTED THIS AT HOME. SHE HAD TO USE SEVERAL TO FIGURE IT OUT AS "SHE PROBED AROUND A LOT" AND WAS A LITTLE SORE DOWN THERE FROM TRYING WITH THE CATHETER SAMPLES. SHE HAD TRIED TO USE A LIGHT ON THE FLOOR BUT IT WAS HARD FOR HER TO HOLD A MIRROR AT THE SAME TIME TO SEE HER URETERAL OPENING WELL. WHEN HER SUPPLIER CALLED HER TO SET HER UP WITH SUPPLIES, SHE RELAYED THIS STRUGGLE TO THEM AND THEY EVEN SENT HER A LEG MIRROR WHICH JUST ARRIVED YESTERDAY IN HER FIRST FULL ORDER. SHE SAID SHE WAS FINALLY, ACTUALLY, SUCCESSFUL PRIOR TO NEEDING TO USE IT. SHE SAID ON HER 4TH TIME
Patient problems: Pain; Urinary Tract Infection
MAUDE report 24817773 ↗
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
- GENTLECATH GLIDE9 models · 572 reports
- ESTEEM52 models · 200 reports · 7 recalls
- ACTIVELIFE21 models · 437 reports · 2 recalls
- 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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