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GENTLECATH AIR 510690Recalls & reported problems

Convatec, Purchasing Department · GENTLECATH AIR MEN CH14 (1X30PK) US · Class 2

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 00768455196272), received between Apr 24, 2023 and May 12, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Tear, Rip or Hole in Device Packaging2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 12, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16918050 ↗
  • MalfunctionApr 24, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16801367 ↗

Other Catheter, Urethral devices

All Catheter, Urethral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.