Medline DYND11501Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884389034439), received between May 31, 2018 and Sep 3, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Deflation Problem; Material Rupture; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50587161 ↗
• MalfunctionSep 2, 2026Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567944 ↗
• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT AS THE RN WAS ADMINISTERING THE MEDICATION, THE INDWELLING BALLOON POPPED INSIDE THE PATIENT. THE RN IMMEDIATELY STOPPED ADMINISTERING MEDICATION, UNCLAMPED THE CATHETER TUBING, DRAINED THE BALLOON WITH A SYRINGE AND REMOVED THE CATHETER. NO ADDITIONAL PATIENT OUTCOME OR MEDICAL INTERVENTION INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25451252 ↗
• MalfunctionMar 17, 2026Material Integrity Problem

  ACCORDING TO THE CUSTOMER, THE FOLEY REQUIRED REPLACEMENT ON (B)(6) 2026 DUE TO THE BALLOON "DEFLATING". THE CUSTOMER REPORTED THAT THEY SUSPECT THE BALLOONS TO HAVE A "HOLE" IN THEM, DUE TO THE IDENTIFICATION OF A HOLE IN A FOLEY BALLOON PRIOR TO INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621977 ↗
• MalfunctionMar 17, 2026Material Puncture/Hole

  ACCORDING TO THE CUSTOMER, THE FOLEY REQUIRED REPLACEMENT ON (B)(6) 2026 DUE TO THE BALLOON DEFLATING, AND THE CUSTOMER REPORTED THAT THEY SUSPECT THE BALLOONS TO HAVE A HOLE DUE TO THE IDENTIFICATION OF A HOLE IN A FOLEY BALLOON PRIOR TO INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620826 ↗
• MalfunctionMar 17, 2026Material Puncture/Hole

  ACCORDING TO THE CUSTOMER, THE FOLEY REQUIRED REPLACEMENT ON (B)(6) 2026 DUE TO THE BALLOON "DEFLATING". THE CUSTOMER REPORTED THAT THEY SUSPECT THE BALLOONS TO HAVE A "HOLE" IN THEM, DUE TO THE IDENTIFICATION OF A HOLE IN A FOLEY BALLOON PRIOR TO INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618300 ↗
• MalfunctionJun 4, 2025Material Integrity Problem; Material Integrity Problem

  "BALLOON ISSUES".

  Patient problems: Insufficient Information

  MAUDE report 22144448 ↗
• MalfunctionJun 4, 2025Material Integrity Problem; Material Integrity Problem

  "BALLOON ISSUES."

  Patient problems: Insufficient Information

  MAUDE report 22140472 ↗
• InjuryJun 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, THERE HAVE BEEN "BALLOON ISSUES" REQUIRING THE FOLEY TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131814 ↗
• InjuryJul 18, 2023Material Rupture; Material Rupture

  ACCORDING TO THE CUSTOMER, THE FOLEY BALLOONS ARE LEAKING AND "CATHETERS ARE FALLING OUT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347084 ↗
• InjuryJul 13, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY THE "CATHETER BULB HAD BROKEN AND PIECES OF THE BULB WERE SEEN IN THE TUBING WHILE IN THE PATIENT".

  Patient problems: Foreign Body In Patient

  MAUDE report 17317778 ↗
• InjuryJun 29, 2022Break

  ACCORDING TO THE FACILITY ON (B)(6) 2022 THE RESIDENTS CATHETER TUBING WAS DISCOVERED TO BE BROKEN, LEAVING A PORTION OF THE TUBING INSIDE THE RESIDENT'S URETHRA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14864599 ↗
• MalfunctionMay 31, 2018Component Falling; Deflation Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED A FOLEY CATHETER RE-INSERTION AFTER THE FOLEY CATHETER REPORTEDLY FELL OUT OF THE PATIENT WITH THE FOLEY CATHETER'S BALLOON DEFLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558529 ↗
• MalfunctionMay 31, 2018Component Falling; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT REQUIRED A FOLEY CATHETER RE-INSERTION AFTER THE FOLEY CATHETER REPORTEDLY FELL OUT OF THE PATIENT WITH THE FOLEY CATHETER'S BALLOON DEFLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7557757 ↗