Dover 6208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521001916), received between Dec 3, 2020 and Dec 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE DRAINAGE BAG WASN'T WORKING PROPERLY. THE FLAP WAS BLOCKING THE URINE FROM DRAINING, UNLESS IT¿S FORCED THROUGH. IT SITS IN WHAT HE'S CALLING A BASIN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CLEAR BASIN THING WHERE THE HOSE CONNECTS TO THE BAG PART, THERE WAS A WHITE FLAP INSIDE THERE THAT LOOKED LIKE THE BACK OF THE CATHETER BAG, AND IT WAS BLOCKING THE URINE FROM DRAINING INTO THE BAG. PER CUSTOMER, YET WHEN HE CLEANED THE BAG, THAT FLAP PUSHED OUT OF THAT BASIN THING, AND IT STILL HAD AN ISSUE IN DRAINING URINE OUT OF THE TUBE INTO THE BAG UNLESS THE URINE WAS FORCED THROUGH. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20884337 ↗
• MalfunctionNov 4, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE DEVICE DOES NOT DRAIN; IT STAYS IN THE TUBE AND LEAKS. NO PATIENT INJURY WAS REPORTED. THE INITIAL REPORTER STATED THAT HE HAS BEEN CONSULTING WITH HIS LOCAL OSTOMY NURSES TO ENSURE WHETHER THE PROBLEM IS WITH THE BAG OR THE WAY IT IS BEING APPLIED. HE PLANS TO SHARE HIS FINDINGS. THE INITIAL REPORTER FURTHER STATED THAT THE INSTRUCTIONS FOR THE USE OF DOVER DRAINAGE BAG 6208 SHOWS THE NIGHT BAG BEING ATTACHED TO A BED RAIL BY CLIPS OR CORD IN A VERTICAL POSITION. WITH THIS ARRANGEMENT, HE FINDS THE BAG DOES NOT DRAIN WELL. HE FOUND A METHOD TO ENSURE THAT IT WILL DRAIN. HE LAYS THE BAG ON IT'S BACK ON THE FLOOR WITH THE TWO HANGER HOOKS EXTENDED AND THEN ATTACHED TO HIS POUCH. THIS HAS WORKED FOR HIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751077 ↗
• MalfunctionJun 4, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE PRODUCT DOESN'T DRAIN. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2021 STATED THAT THE URINE WAS DRAINING FROM THE OSTOMY POUCH THROUGH THE TUBE TO THE DRAINAGE BAG. BUT IT WAS HELD UP IN THE "BUBBLE" AT THE TOP OF THE DRAINAGE BAG AND NOT GOING INTO THE BAG ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942579 ↗
• MalfunctionDec 3, 2020No Flow; No Flow

  THE CUSTOMER REPORTED THAT THE PLASTIC CHAMBER CONNECTED TO THE BAG DOES NOT ALLOW LIQUID TO PASS THROUGH TO THE BAG. THE BAG ALSO LEAKS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10941504 ↗