Dover 3450LFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521009585), received between Aug 14, 2019 and Mar 10, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 1, 2022Open, Classified

   Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

   Z-0361-2023 · Root cause: Equipment maintenance · FDA record ↗

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.

• MalfunctionMar 10, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED DIFFICULTY GETTING URINE RETURN WHEN USING THE INTERMITTENT CATHETER. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER CANNOT CONFIRM THE LOT NUMBER THAT EXPERIENCED THE ISSUE. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522872 ↗
• MalfunctionJul 5, 2022Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTS: THERE WERE MULTIPLE OCCURRENCES WITH ONE PATIENT WHERE THE DEVICES WERE NOT WORKING. FOR INSTANCE, TWO DEVICE KITS WERE USED WITH NO URINE RETURN, BUT WITH A THIRD TRY WAS SUCCESSFUL. THE NEXT TIME THIS PATIENT NEEDED TO BE CATHETERIZED, THE SAME THING HAPPENED. THE CUSTOMER HAS PULLED ALL KITS THAT HAD THE SAME LOT NUMBER AS THE AFFECTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14919595 ↗
• MalfunctionAug 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT WHILE DOING A STRAIGHT CATHETER ON A MALE PATIENT, HE NOTICED THAT PART WAY THROUGH POSITIONING THE STRAIGHT CATHETER, URINE WAS FLOWING ONTO THE PADDING THEY PLACED TO PROTECT THE PATIENT AND BEDDING FROM SPILLS. THE CATHETER HAS SEPARATED WHERE THE BLUE PORTION OF THE TUBE AND THE WHITE PORTIONS MEET. IT WAS RECONNECTED AND THE HEALTH CARE PROVIDER (HCP) MADE SURE THERE WAS NO PULLING FROM THE WEIGHT OF THE URINE BAG BUT IT SEPARATED AGAIN. THE HCP COMPENSATED BY MAKING SURE THEY HELD THE CONNECTION SECURELY UNTIL THE BLADDER HAS BEEN DRAINED OF URINE AND THE CATHETER WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8893639 ↗