GENTLECATH 421909Recalls & reported problems
Convatec, Purchasing Department · GENTLECATH LOWFRIC TMNN CH12 · Class 2
Quick summary
This Convatec GentleCath LowFRIC Tiemann catheter is a single-use urethral catheter with a curved tip. The 67 reports filed in the past 12 months (none the year before) mostly describe the guide notch on the funnel not lining up with the curved tip, along with catheters arriving incorrectly assembled. There are no deaths and one report of an injury, a user mentioning repeated urinary tract infections. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 30768455153818), received between Jan 13, 2026 and Jul 20, 2026 — classified as 66 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (66 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, 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
- Device Misassembled During Manufacturing /Shipping66
Patient problems
- No Clinical Signs, Symptoms or Conditions66
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24102061 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24102060 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24102059 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24102057 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24102056 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101849 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101848 ↗MalfunctionJan 16, 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 24101847 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101846 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101596 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101595 ↗MalfunctionJan 16, 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 24101593 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101541 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101539 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101538 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101536 ↗MalfunctionJan 16, 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 24101535 ↗MalfunctionJan 16, 2026Device Misassembled During Manufacturing /Shipping
END USER REPORTS THE NOTCH ON THE CATHETER FUNNEL IS NOT ALIGNED TO THE COUDE TIP. THERE WAS NO HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101534 ↗MalfunctionJan 16, 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 24101289 ↗
Other Catheter, Urethral devices
- Bardex® All-Silicone Foley Catheter 165814C. R. Bard, Inc. · CATHETER, URETHRAL275 reports
- GENTLECATH 421911Convatec, Purchasing Department · Catheter, Urethral234 reports
- GENTLECATH 421910Convatec, Purchasing Department · Catheter, Urethral122 reports
- CURE CATHETER M16CConvatec, Purchasing Department · Catheter, Urethral95 reports
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82124Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82144Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.