Medline DYND160116CRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884389118757), received between Dec 5, 2025 and Dec 11, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

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.

• InjuryDec 11, 2025Migration; Migration

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, PATIENT WENT TO THE EMERGENCY ROOM A FEW HOURS AFTER CHANGING CATHETER AND WAS EXPERIENCING "SUDDEN NEW ONSET OF PENILE PAIN." CATHETER BALLOON WAS BELIEVED TO BE IN THE URETHRA.

  Patient problems: Pain; Unspecified Blood or Lymphatic problem

  MAUDE report 23782600 ↗
• InjuryDec 11, 2025Migration; Migration

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 WITHIN "A FEW DAYS" AFTER CATHETER INSERTION, THE PATIENT BEGAN COMPLAINING OF "PENILE PAIN", AND AN ULTRASOUND SHOWED THAT THE BALLOON "IN THE PROSTATE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 23780210 ↗
• InjuryDec 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2025, THE PATIENT RETURNED FROM THE EMERGENCY ROOM AFTER CATHETER MANIPULATION TO CHANGE POSITION AND A FEW HOURS LATER, WATER WAS NOTED ON BED. THE CATHETER WAS REMOVED AND WAS NOTED TO HAVE SLIT IN IT AND THEREFORE ALL THE "WATER" WAS MISSING.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23779787 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A CATHETER WAS REMOVED AND REPLACED DUE TO SEVERE PENILE AND PELVIC PAIN.

  Patient problems: Pain; Pelvic Pain

  MAUDE report 23779267 ↗
• InjuryDec 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2025, "HE WAS COMPLAINING OF PENILE PAIN AND DISCOMFORT".

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23778718 ↗
• MalfunctionDec 8, 2025Inflation Problem; Inflation Problem

  BALLOON BECAME DEFLATED WHILE IN USE.

  Patient problems: Pain

  MAUDE report 23745021 ↗
• InjuryDec 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  "CT IMAGING SHOWED CATHETER BALLOON WAS IN THE PROSTATE".

  Patient problems: Pain

  MAUDE report 23732473 ↗
• InjuryDec 5, 2025Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  ACCORDING TO THE FACILITY, A FOLEY CATHETER WAS INSERTED "WITHOUT ISSUE," AND WITHIN A FEW DAYS, THE PATIENT WAS COMPLAINING OF "PENILE PAIN" AND LAB WORK SHOWED "INCREASED WHITE BLOOD CELL COUNT WITHOUT KNOWN CAUSE." A CT WAS PERFORMED AND THE "BALLOON WAS NOTED TO BE IN THE PROSTATE."

  Patient problems: Genital Bleeding; High White Blood Cell Count; Pain; Swelling/ Edema

  MAUDE report 23729918 ↗