Medline DYND11216Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10080196726769), received between Aug 2, 2018 and Sep 3, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Failure to Deflate

  Patient problems: Anxiety

  MAUDE report 50598541 ↗
• MalfunctionJul 28, 2026Material Too Rigid or Stiff

  Patient problems: Insufficient Information

  MAUDE report 50060261 ↗
• MalfunctionMar 22, 2023Deflation Problem

  PT SEEN IN CANCER CENTER FOR TREATMENT NUMBER 3 BLADDER INSTILLATION OF GEMZAR CHEMO. COUDE TIP 16FR FOLEY INSERTED BY RN WITH NO ISSUES. TREATMENT PROCEEDED WITH NO ISSUES. UPON COMPLETION OF TREATMENT, RN ATTEMPTED TO DEFLATE BALLOON AND REMOVE CATHETER. BALLOON DID NOT DEFLATE WITH NO SALINE WITHDRAWN FROM BALLOON UPON ATTEMPT. RN TROUBLESHOOTED FOLEY BALLOON WOULD TILL NOT DEFLATE. ON CALL UROLOGIST DR (B)(6)CONSULTED. RN CUT CATHETER BY VALVE OF BALLOON AS INSTRUCTED. NO FLUID RETURN AND BALLOON DID NOT INFLATE. RN DISCUSSED FURTHER WITH DR O'NEILL AND PLAN IN PLACE FOR PT TO PROCEED TO DOVER OFFICE OF MANCHESTER UROLOGY FOR FURTHER EVALUATION. FOLEY BAG CHANGED PER CHEMO PRECAUTIONS TO NEW EMPTY BAG, AS IT HAD BEEN DRAINING WELL. PT LEFT AMBULATORY AND STABLE, FAMILY DRIVING TO UROLOGIST OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598370 ↗
• InjuryDec 19, 2021Material Rupture

  IT WAS REPORTED THAT A PATIENT WAS USING A FOLEY CATHETER FOR SHORT TERM PURPOSES AND AFTER APPROXIMATELY 2 DAYS OF THE CATHETER BEING IN PLACE THE BALLOON ON THE FOLEY CATHETER DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13040419 ↗
• InjuryJul 2, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT A LATEX FOLEY CATHETER WAS INSERTED INTO THE ILEOSTOMY OF A PATIENT(WITH KNOWN LATEX ALLERGY). THE ILEOSTOMY DEVELOPED SLOUGHING AND REQUIRED SURGICAL DEBRIDEMENT.

  Patient problems: Local Reaction

  MAUDE report 8753492 ↗
• InjuryAug 2, 2018Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING AND OCCLUDED. THE FOLEY CATHETER WAS REMOVED AND A NEW FOLEY CATHETER WAS INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742656 ↗