Dover 8887605189 (UDI 20884521016702)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521016702), received between Jan 26, 2023 and Jul 25, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE CATHETER'S BALLOON BROKE AND THE CATHETER FELL OUT. THE CATHETER HAD TO BE CHANGED 4 OR 5 TIMES OVER THE PERIOD OF ONE OR TWO MONTHS DUE TO THIS. THE EXACT QUANTITY AND EVENT DATES ARE NOT KNOWN. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393918 ↗
• MalfunctionJun 23, 2023Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE FOLEY BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195354 ↗
• InjuryJan 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CONICAL END OF THE CATHETER WAS MISSING. PER CUSTOMER, THE CATHETER WAS PUT INTO THE PATIENT, AND IT WAS DURING SURGERY THAT THEY NOTICED THAT CONICAL END WAS MISSING. THE SURGEON REMOVED THE CATHETER FROM THE PATIENT AND PUT ANOTHER ONE IN, TO COMPLETE THE SURGERY. THE SURGEON DID SEVERAL MANIPULATIONS TO FIND THE END OF THE CATHETER IN THE ABDOMEN BUT WITHOUT SUCCESS AND TO COMPLETE THE SURGERY HE DID A CYSTOSCOPY AND FOUND NOTHING EITHER. THE CUSTOMER FURTHER STATED THAT MAYBE THERE WAS NO CONICAL END BEFORE THE INSERTION, BUT THEY CANNOT CONFIRM IT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT HAD ROBOTIC RADICAL PROSTATECTOMY SURGERY AND DURING THE SURGERY THEY NOTICED THAT CONICAL END OF THE CATHETER WAS MISSING. THE CYSTOSCOPY PROCEDURE WAS PERFORMED TO FIND THE MISSING CONICAL END, BECAUSE THIS PROCEDURE IS NOT USUALLY DONE AFTER A PROSTATECTOMY. PER CUSTOMER, AT THE TIME OF THE INCIDENT THE PATIENT WAS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246280 ↗