GENTLECATH TIEMANN 3213182Recalls & reported problems
Convatec, Purchasing Department · Gentlecath™ Uncoated Intermittent Urinary Catheter, Tiemann Tip, Male - Fr/Ch16, 16" · Class 2
All models of GENTLECATH TIEMANN (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455145546), received between Oct 19, 2022 and Sep 3, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (10 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. 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
- Device Misassembled During Manufacturing /Shipping10
- Material Twisted/Bent2
Patient problems
- Bruise/Contusion6
- Hemorrhage/Blood Loss/Bleeding2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionDec 18, 2023Device Misassembled During Manufacturing /Shipping; Device 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 18349542 ↗MalfunctionDec 18, 2023Device Misassembled During Manufacturing /Shipping; Device 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 18349505 ↗MalfunctionOct 19, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Bruise/Contusion
MAUDE report 15633652 ↗MalfunctionOct 19, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Bruise/Contusion
MAUDE report 15633649 ↗MalfunctionOct 19, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Bruise/Contusion
MAUDE report 15633634 ↗MalfunctionOct 19, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Bruise/Contusion
MAUDE report 15633555 ↗MalfunctionOct 19, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Bruise/Contusion
MAUDE report 15633547 ↗MalfunctionOct 19, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: Bruise/Contusion
MAUDE report 15633521 ↗
Other Catheter, Urological devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 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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