GENTLECATH AIR 510696Recalls & reported problems
Convatec, Purchasing Department · GENTLECATH AIR MEN COUDE CH14 1X30 US · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00768455196630), received between Jun 5, 2024 and Aug 12, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (3 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
- Difficult to Open or Remove Packaging Material3
- Device Misassembled During Manufacturing /Shipping2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Discomfort2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220639 ↗MalfunctionAug 12, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220636 ↗MalfunctionAug 12, 2026Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220630 ↗MalfunctionJun 6, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE COUDE TIP IS ANGLED AS MUCH AS 90 DEGREES AWAY FROM THE SPINAL (NATURAL COIL) OF THE CATHETER AND DUE TO THIS, THEY ARE VERY HARD TO INSERT IN URETHRA CORRECTLY WITH COUDE TIP UP AS HE HAS TO TRY TO TURN THEM TO GET THEM TO GO IN. HE SAID THEY JUST CAUSE MOMENTARY DISCOMFORT WHEN TRYING TO INSERT ONES LIKE THIS AND OFTEN HE CANNOT EVEN GET THEM. DENIES ANY BLEEDING OR LASTING DISCOMFORT. HE DESCRIBES THIS MORNING HE HAD TO DISCARD 3 BEFORE FINALLY FINDING ONE WITHOUT DEFECT AND HE COULD GET IN EASILY. ". THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE DEFECT.
Patient problems: Discomfort
MAUDE report 19481236 ↗MalfunctionJun 5, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
END USER STATES "THE COUDE TIP IS ANGLED AS MUCH AS 90 DEGREES AWAY FROM THE SPINAL (NATURAL COIL) OF THE CATHETER AND DUE TO THIS, THEY ARE VERY HARD TO INSERT IN URETHRA CORRECTLY WITH COUDE TIP UP AS HE HAS TO TRY TO TURN THEM TO GET THEM TO GO IN. HE SAID THEY JUST CAUSE MOMENTARY DISCOMFORT WHEN TRYING TO INSERT ONES LIKE THIS AND OFTEN HE CANNOT EVEN GET THEM. DENIES ANY BLEEDING OR LASTING DISCOMFORT. HE DESCRIBES THIS MORNING HE HAD TO DISCARD 3 BEFORE FINALLY FINDING ONE WITHOUT DEFECT AND HE COULD GET IN EASILY. "
Patient problems: Discomfort
MAUDE report 19467845 ↗
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
- GENTLECATH 421909Convatec, Purchasing Department · Catheter, Urethral66 reports
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
- Onli 82144Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
- Onli 82164Hollister Incorporated · CATHETER, URETHRAL1 recall1 report
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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