Medline DYND11760Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10080196726547), received between Jan 3, 2019 and Jul 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063708 ↗
• MalfunctionJun 17, 2026Failure to Deflate

  IT WAS REPORTED THAT BALLOONS WERE NOT FULLING DEFLATING INSIDE PATIENT'S BLADDER.

  Patient problems: Insufficient Information

  MAUDE report 25540697 ↗
• MalfunctionApr 16, 2026Break

  ACCORDING TO THE FACILITY ON 2/3, "BOTH OF THE BALLONS ON THIS BURST".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899142 ↗
• MalfunctionApr 16, 2026Break

  ACCORDING TO THE CUSTOMER, "BOTH OF THE BALLONS ON THIS BURST."

  Patient problems: Insufficient Information

  MAUDE report 24899108 ↗
• MalfunctionMay 14, 2021Device Slipped; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED VIA MED WATCH REPORT (NUMBER (B)(4)) A "PATIENT UNDERWENT ROBOTIC PROSTATECTOMY. PATIENT WAS DISCHARGED HOME WITH SILASTIC FOLEY CATHETER. PATIENT PRESENTED TO EMERGENCY DEPT. TWO AND A HALF WEEKS POST OP, AFTER CATHETER BALLOON MALFUNCTIONED AND CATHETER "SLIPPED OUT." PATIENT REQUIRED FOLEY CATHETER REPLACEMENT VIA CYSTOSCOPY IN THE ED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827903 ↗
• MalfunctionApr 14, 2021Device Slipped

  THERE HAVE BEEN A FEW ACCOUNTS OF MEDLINE SILICONE-ELASTOMER COATED LATEX CATHETERS DYSFUNCTIONS. PATIENT UNDERWENT ROBOTIC PROSTATECTOMY. PATIENT WAS DISCHARGED HOME WITH SILASTIC FOLEY CATHETER. PATIENT PRESENTED TO EMERGENCY DEPT TWO AND A HALF WEEKS POST OP, AFTER CATHETER BALLOON MALFUNCTIONED AND CATHETER "SLIPPED OUT." PATIENT REQUIRED FOLEY CATHETER REPLACEMENT VIA CYSTOSCOPY IN THE ED.

  Patient problems: Insufficient Information

  MAUDE report 11663607 ↗
• MalfunctionJan 3, 2019Deflation Problem

  IT WAS REPORTED THAT THE URINARY CATHETER'S BALLOON DEFLATED AND IT WAS REQUIRED TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8213643 ↗