Dover P4P16SDRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884521029597), received between Oct 8, 2020 and Sep 11, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: WE HAD AN ISSUE WITH THE FOLEY TRAYS IN ONE OF OUR NEURO CASES YESTERDAY. THE FOLEY CATHETER FELL OUT AFTER THE SURGEON INSERTED IT AND IT FELL OUT AFTER THE BALLOON WAS DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725444 ↗
• MalfunctionSep 11, 2023Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: WE HAD AN ISSUE WITH THE FOLEY TRAYS IN ONE OF OUR NEURO CASES YESTERDAY. FOUR OUT OF THE FIVE LOTS BELOW HAD EITHER A HOLE IN THE BAG OR THE BALLOON WOULD DEFLATE. PER ADDITIONAL INFORMATION PROVIDED ON 9/5/23, THE FOLEY CATHETER BALLOON WAS CHECKED AND THE BALLOON LEAKED OUT FLUID & WOULD NOT STAY INSERTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719752 ↗
• MalfunctionSep 11, 2023Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: WE HAD AN ISSUE WITH THE FOLEY TRAYS IN ONE OF OUR NEURO CASES YESTERDAY. THE FOLEY CATHETER BAG STARTED TO LEAK AND THAN IT WAS NOTICED THAT THE FOLEY CATHETER BALLOON HAD DEFLATED AND CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719631 ↗
• MalfunctionSep 11, 2023Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: WE HAD AN ISSUE WITH THE FOLEY TRAYS IN ONE OF OUR NEURO CASES YESTERDAY. FOUR OUT OF THE FIVE LOTS BELOW HAD EITHER A HOLE IN THE BAG OR THE BALLOON WOULD DEFLATE. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2023, THE FOLEY CATHETER DEFLATED AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719530 ↗
• MalfunctionMay 8, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THEY ATTEMPTED THE PLACEMENT OF THE FOLEY CATHETER AND URINE RETURN WAS OBSERVED. THE BALLOON WAS INFLATED. PATIENT COMPLAINED OF BURNING UPON INFLATION. THE CATHETER THEN CAME OUT DESPITE INFLATING THE BALLOON. THE AREA AROUND THE BALLOON APPEARED RIPPED. THIS HAPPENED TWO TIMES. AFTER SPEAKING TO THE PRIMARY RN, THEY BELIEVE THAT IT MAY HAVE BEEN THE PATIENT'S ANATOMY THAT CAUSED THE ISSUE. THEY OPENED A THIRD KIT AND INFLATED AND DEFLATED THE BALLOON WITHOUT ANY ISSUE. HOWEVER, THEY DO NOT REALLY KNOW SO STILL REPORTED IT.

  Patient problems: Burning Sensation

  MAUDE report 16886859 ↗
• InjuryFeb 21, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT A FOLEY CATHETER WAS INSERTED WITH KIT BY THE MEDICAL DOCTOR (MD) AT THE START OF THE PROCEDURE. DURING THE PROCEDURE, APPROXIMATELY 20 MINUTES AFTER INSERTING LAPAROSCOPIC PORTS, THERE WAS AN AUDIBLE POP SOUND. THE MD STOPPED THE PROCEDURE AND THE STAFF CHECKED THE PATIENT AND SURROUNDINGS. THE MD ALSO VISUALLY CHECKED THE PATIENT'S ABDOMINAL CAVITY WITH A SCOPE. NO AREAS OF INJURY OR NOTED CONCERNS. AT THE END OF THE PROCEDURE, THE MD WENT TO REMOVE THE FOLEY. UPON PULLING BACK THE BALLOON FLUID, THEY NOTED URINE IN RETURN. THE FOLEY WAS REMOVED WITH A NOTED RIP IN THE BALLOON. A CYSTOSCOPY WAS DONE WITH NO APPEARANCE OF RETAINED PRODUCT. SAMPLE IS NOT AVAILABLE TO BE RETURNED HOWEVER A PHOTO IS ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13572880 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE FOLEY CATHETER DISCONNECTED FROM THE DRAINAGE BAG WHERE THE CATHETER IS CONNECTED TO THE BAG AND 'TAPED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166291 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE FOLEY CATHETER DISCONNECTED FROM THE DRAINAGE BAG WHERE THE CATHETER IS CONNECTED TO THE BAG AND 'TAPED'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165290 ↗
• MalfunctionOct 8, 2020Connection Problem; Connection Problem

  CUSTOMER REPORTS: A PATIENT'S FOLEY DISCONNECTED AND SUBSEQUENTLY CONTRACTED A UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 10648541 ↗