GENTLECATH TIEMANNRecalls & reported problems across all models
Convatec, Purchasing Department · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 209
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 3 models of GENTLECATH TIEMANN by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 209 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2022 and Sep 14, 2026 — classified as 1 injury, 208 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (204 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 TIEMANN problems
Device problems
- Device Misassembled During Manufacturing /Shipping204
- Device Contaminated During Manufacture or Shipping2
- Material Twisted/Bent2
- Sharp Edges2
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions194
- Hemorrhage/Blood Loss/Bleeding8
- Bruise/Contusion6
- Tissue Breakdown2
- Urinary Tract Infection1
GENTLECATH TIEMANN models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GENTLECATH TIEMANN 501014Catheter, Urological111 reports
- GENTLECATH TIEMANN 501013Catheter, Urological88 reports
- GENTLECATH TIEMANN 3213182Catheter, Urological10 reports
Recent GENTLECATH TIEMANN adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Device Misassembled During Manufacturing /Shipping
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50758465 ↗MalfunctionSep 14, 2026Device Misassembled During Manufacturing /Shipping
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50758458 ↗MalfunctionNov 25, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED "THE END USER BOUGHT 2 BOXES OF THE PRODUCT AND HE SAYS THAT SOME CATHETERS REMAIN TO HAVE THE COUDÉ TIP NOT ALIGNED WITH THE RAISED FIN FOR THE COUDÉ ON THE FUNNEL END."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644593 ↗MalfunctionOct 15, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER REPORTS THAT IN ABOUT 1/3 OF EVERY BOX, THERE ARE CATHETERS THAT HAVE THE COUDÉ FIN NOT ALIGNED WITH THE COUDÉ TIP. HE SAYS THIS ISSUE HAS BEEN ONGOING THAT HE STOPPED COUNTING. NO PHOTO AVAILABLE. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS WITH UNKNOWN LOT NUMBERS OF THE SAME CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299451 ↗MalfunctionSep 3, 2025Device Misassembled During Manufacturing /Shipping; Material Twisted/Bent; Device Misassembled During Manufacturing /Shipping; Material Twisted/Bent
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22951263 ↗MalfunctionSep 3, 2025Device Misassembled During Manufacturing /Shipping; Material Twisted/Bent; Device Misassembled During Manufacturing /Shipping; Material Twisted/Bent
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22951260 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164627 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164626 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164625 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164624 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164623 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164622 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164621 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164620 ↗MalfunctionJun 8, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE FUNNEL NOT ALIGNED WITH THE COUDÉ TIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164619 ↗
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
- GENTLECATH8 models · 430 reports
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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