GENTLECATH GLIDE 421571Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30768455143581), received between Mar 20, 2025 and Sep 23, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  End user reports she has a lot of bladder/ health concerns mentioning IC and overactive bladder and she constantly has the feeling of a UTI, constant burning and irritation is her normal due to her conditions stating she has even tried bladder installations that have not helped her condition in past. She said she last had a diagnosed UTI in July. Following the diagnosis and treatment of her UTI in July she was placed on Methenamine for UTI prevention which she said she has had 2 subsequent urine cultures which were negative. Her cultures were not done due to the bleeding event but due to just the overall feeling she always has a UTI. She does not take blood thinners but does have history of blood clots/pulmonary embolism in her past. She is planning to follow up with a Urogynecologist. No additional information is available. This eMDR is to address the UTI's with unknown lot and market unit.

  Patient problems: Urinary Tract Infection

  MAUDE report 50867782 ↗
• MalfunctionDec 2, 2025Tear, 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 23692147 ↗
• MalfunctionDec 2, 2025Tear, 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 23692146 ↗
• MalfunctionDec 2, 2025Tear, 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 23692143 ↗
• MalfunctionAug 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  END USER IS A 70-YR OLD FEMALE, REPORTS '1/2 INCH LIVE DARKER COLORED LIVE WORMS FOUND IN PACKAGING OF CATHETERS' IN (B)(6) (LOT # UNKNOWN) AND IN (B)(6) (LOT# AVAILABLE). END USER WHO HAS BEEN USING THIS PRODUCT FOR 4 YRS, GETS 5 BOXES MONTHLY. SHE SAID SHE FIRST NOTICED THIS CONCERN IN A SHIPMENT IN (B)(6) OF THIS YEAR AND THEN EARLIER THIS WEEK IN A BOX. SHE SAID THE WORMS SHE COULD SEE THROUGH THE PACKAGING IN BOTH CASES AND LOOKED TO BE THE SAME KIND/ SPECIES OF WORM AS THEY WERE THE "SAME FORM". THEY ARE LONG (ABOUT HALF AN INCH) AND SLENDER AND "LOOKED LIKE A LITTLE WORM" SEEN THROUGH THE PACKAGING. SHE DID NOT SEE ANY HOLES ON ANY OF THE PACKAGING AT ALL/ ALL WAS INTACT AND PER HER DESCRIPTION IT LOOKED LIKE THE WORMS WERE PACKAGED INSIDE THE SEALED CATHETER PACKAGING. SHE MENTIONED THE WORMS SHE SAW IN JUNE LOOKED TO BE ALIVE AS THEY WERE WIGGLING AND DARKER IN COLOR COMPARED TO THE DEAD WORM WHICH WAS LIGHTER BEIGE IN COLOR SHE FOUND IN AUGUST. SHE DID NOT USE ANY OF THESE BUT WAS ABLE TO NOTE THE LOT NUMBER ON THAT CATHETER PRIOR TO DISCARDING IT. PHOTOS WERE PROVIDED. THIS REPORT CAPTURES MALFUNCTION OBSERVED IN THE AUGUST DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862413 ↗
• MalfunctionMay 29, 2025Sharp Edges; Sharp Edges

  END USER REPORTS, "CATH TIP IS ROUGH AND CAUSED BLEEDING." NO FURTHER INFORMATION OBTAINED. NO PHOTO AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 22107109 ↗
• MalfunctionMay 27, 2025Sharp Edges; Sharp Edges

  END USER REPORTS, "CATH TIP IS ROUGH AND CAUSED BLEEDING." NO FURTHER INFORMATION OBTAINED. NO PHOTO AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 22092241 ↗
• MalfunctionMar 20, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED "PER CUSTOMER STATES PATIENT GOT UTI FROM SHARP CATHETER AND BLEEDING. NO MEDICAL ATTENTION REPORTED. PATIENT HAS USED BEFORE."

  Patient problems: Urinary Tract Infection

  MAUDE report 21651712 ↗