GENTLECATH NELATONRecalls & reported problems across all models

We found 2 models of GENTLECATH NELATON by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 182 adverse event reports in the FDA's MAUDE database, received between Aug 19, 2021 and Mar 2, 2026 — classified as 5 injuries, 177 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (100 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GENTLECATH NELATON problems

GENTLECATH NELATON models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GENTLECATH NELATON 501003

  Catheter, Urological
  129 reports
• GENTLECATH NELATON 501004

  Catheter, Urological
  53 reports

Recent GENTLECATH NELATON adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Tear, Rip or Hole in Device Packaging

  END USER REPORTS "SOME SEEM MORE DIFFICULT TO PEEL BACK THAN OTHERS. HE DOES NOT HAVE ANY LOT INFO AS SAID IT HAPPENS SPORADICALLY. HE SAID SOME JUST SEEM MORE DIFFICULT TO PEEL BACK WHICH IS A NUISANCE TO HIM ESPECIALLY AT NIGHT WHEN HE CATHS. HE NOTES SOMETIMES BECAUSE IT IS SO DIFFICULTY TO PEEL BACK SOMETIMES THE PAPER WILL TEAR IN VARIOUS AREAS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482912 ↗
• MalfunctionMar 2, 2026Tear, Rip or Hole in Device Packaging

  END USER REPORTS "SOME SEEM MORE DIFFICULT TO PEEL BACK THAN OTHERS. HE DOES NOT HAVE ANY LOT INFO AS SAID IT HAPPENS SPORADICALLY. HE SAID SOME JUST SEEM MORE DIFFICULT TO PEEL BACK WHICH IS A NUISANCE TO HIM ESPECIALLY AT NIGHT WHEN HE CATHS. HE NOTES SOMETIMES BECAUSE IT IS SO DIFFICULTY TO PEEL BACK SOMETIMES THE PAPER WILL TEAR IN VARIOUS AREAS." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS ASSOCIATED WITH THE PACKAGING DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482741 ↗
• MalfunctionDec 13, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20921875 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20921350 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20921108 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920960 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920956 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920849 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920823 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920812 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920690 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920646 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920608 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920606 ↗
• MalfunctionDec 12, 2024Sharp Edges; Sharp Edges

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

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20920527 ↗

Other Convatec, Purchasing Department products

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