Dover 402716 (UDI 10884521016163)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521016163), received between Jul 6, 2021 and Feb 20, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BALLOON ON FOLEY BURST WITHIN THE FIRST DAY OF USE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422222 ↗
• MalfunctionDec 18, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT A DEFECTIVE CATHETER WAS INSERTED. THE CATHETER WAS NOT DRAINING AND COULD NOT BE FLUSHED. THE PATIENT HAS A NEOBLADDER, SO THIS COULD HAVE BEEN SERIOUS, BUT THANKFULLY IT LEAKED AROUND THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350232 ↗
• MalfunctionDec 18, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE BALLOONS IN THIS LOT OBSTRUCT THE CATHETER ONCE INFLATED AND IT OCCURRED ON SEVERAL OCCASIONS THAT THEY HAD A LOT OF DIFFICULTY DEFLATING THE BALLOON. ON ONE OCCASION, THE PATIENT WAS TRAUMATIZED EMOTIONALLY AND PHYSICALLY AS THE CATHETER HAD TO BE NOT ONLY CHANGED IMMEDIATELY AS IT WAS DEFECTIVE, BUT THEY HAD TO INCREASE A SIZE TO GUARANTEE SUCCESS. THE MULTIPLE CHANGES, IRRIGATIONS AND INCREASE IN SIZE GAVE THE PATIENT A LOT OF PAINFUL SPASMS.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 18349497 ↗
• MalfunctionNov 30, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE BALLOON OBSTRUCTS THE CATHETER ONCE INFLATED AND THEY HAD A LOT OF DIFFICULTY DEFLATING THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242433 ↗
• MalfunctionNov 30, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE BALLOON OBSTRUCTS THE CATHETER ONCE INFLATED AND THEY HAD A LOT OF DIFFICULTY DEFLATING THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242425 ↗
• MalfunctionNov 30, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE BALLOON OBSTRUCTS THE CATHETER ONCE INFLATED AND THEY HAD A LOT OF DIFFICULTY DEFLATING THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242416 ↗
• MalfunctionNov 30, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE BALLOON OBSTRUCTS THE CATHETER ONCE INFLATED AND THEY HAD A LOT OF DIFFICULTY DEFLATING THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242409 ↗
• MalfunctionNov 29, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE BALLOONS IN THIS LOT OBSTRUCT THE CATHETER ONCE INFLATED AND IT OCCURRED ON SEVERAL OCCASIONS THAT THEY HAD A LOT OF DIFFICULTY DEFLATING THE BALLOON. ON ONE OCCASION THE BALLOON DID NOT DEFLATE AND THEY HAD TO REMOVE THE CATHETER WITH THE BALLOON PARTIALLY DEFLATED CAUSING TRAUMA TO A PATIENT'S URETHRA. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD MINOR TRAUMA TO THE URETHRA AS THE BALLOON COULD NOT BE DEFLATED AND IT WAS EVENTUALLY REMOVED WITH ABOUT 2ML STILL IN THE BALLOON, WHICH IS MINOR. THE RECOVERY WAS ALMOST IMMEDIATE.

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

  MAUDE report 18235129 ↗
• MalfunctionNov 21, 2023Material Rupture; Material Rupture

  CUSTOMER REPORTS: THERE WAS AN A HOLE IN THE URINARY TUBE BALLOON THEREFORE IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. PER ADDITIONAL INFORMATION RECEIVED ON 11/21/23, THE HOLE WAS AT THE LEVEL OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185773 ↗
• MalfunctionSep 11, 2023Complete Blockage; Unintended Deflation; Complete Blockage; Unintended Deflation

  THE CUSTOMER REPORTED THAT WHILE TRYING TO REMOVE THE CATHETER DUE TO AN OBSTRUCTION, THE NURSE ASPIRATED THE BALLOON AND THERE WAS ONLY 4 CC REMAINING BUT 10 CC WAS PUT IN THE BALLOON TO INFLATE IT. ADDITIONAL INFORMATION RECEIVED ON 11 SEPT 2023 CLARIFIED THAT THE CATHETER WAS BLOCKED, NOT KINKED AND THE OBSTRUCTION PREVENTED URINE FROM LEAKING THROUGH THE CATHETER AND INSTEAD LEAKED AROUND IT. THE CAREGIVER ATTEMPTED TO IRRIGATE WITHOUT SUCCESS, SO A CATHETER CHANGE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17723538 ↗
• MalfunctionJul 6, 2021Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED WHEN REMOVING THE CATHETER, THE AUXILIARY NURSE WITHDREW 10ML OF THE LIQUID BUT THE CATHETER DID NOT WANT TO COME OUT, EVEN AFTER IRRIGATION. SHE THEN PULLED IT THINKING IT WAS JUST STUCK, BUT THE BALLOON WAS FULL OF AIR. SHE HAD TO PRESS ON THE BALLOON AND EXTRACT AIR IN ORDER TO MAKE IT DEFLATE. ADDITIONAL INFORMATION RECEIVED STATED THERE WAS A COMPLETE TEAR OF THE URETHRA (MALE), HEMORRHAGE, AND SEVERE PAIN. SUBSEQUENTLY HYPERTHERMIA AND A URINARY TRACT INFECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 12123073 ↗