GENTLECATH AIR 510691Recalls & reported problems
Convatec, Purchasing Department · GENTLECATH AIR MEN CH16 (1X30PK) US · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00768455196302), received between Sep 14, 2026 and Sep 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 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 Remove2
Patient problems
- Distress2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Difficult to Remove
It was reported '"The catheter itself has been glued to the bottom of the envelope, making it very difficult or impossible to remove -- often causing the water from the enclosed pouch to spill. I don't use them often, but in the situations where this happens it is extremely inconvenient, time-consuming, or even embarrassing. I only found this defect in a handful of items. It looked like the "heat spot weld" in the package center (which I assume is to keep the tube coiled) was misplaced and it caught part of the turn or the sliding sleeve."
Patient problems: Distress
MAUDE report 50752931 ↗MalfunctionSep 14, 2026Difficult to Remove
It was reported '"The catheter itself has been glued to the bottom of the envelope, making it very difficult or impossible to remove -- often causing the water from the enclosed pouch to spill. I don't use them often, but in the situations where this happens it is extremely inconvenient, time-consuming, or even embarrassing. I only found this defect in a handful of items. It looked like the "heat spot weld" in the package center (which I assume is to keep the tube coiled) was misplaced and it caught part of the turn or the sliding sleeve."This eMDR covers the unknown number of catheters associated with the defect.
Patient problems: Distress
MAUDE report 50752892 ↗
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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