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Dover 7000Recalls & reported problems

Cardinal Health, Inc. · Urine Meter,Luer-Slip Sampling · Class 2

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521002173), received between Aug 11, 2022 and Nov 22, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

Reports received per month

Nov 2023: 5 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Obstruction of Flow5
  • Improper Flow or Infusion3

Patient problems

  • Discomfort3
  • No Clinical Signs, Symptoms or Conditions3
  • Pain3
  • Urinary Retention2
  • Chills1
  • Fever1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 22, 2023Improper Flow or Infusion; Improper Flow or Infusion

    THE CUSTOMER REPORTED IN THE MULTI-PURPOSE INTENSIVE CARE UNIT, IT WAS FOUND THE URINE WAS NOT FLOWING IN THE DEVICE. THIS PROBLEM IS RECURRENT ACCORDING TO THE HEALTH CARE TEAM. THIS INCIDENT CAUSES DISCOMFORT AND PAIN TO THE PATIENTS AND PUT THEM AT RISK OF URINARY GLOBES.

    Patient problems: Discomfort; Pain

    MAUDE report 18192834 ↗
  • MalfunctionNov 22, 2023Improper Flow or Infusion; Improper Flow or Infusion

    THE CUSTOMER REPORTED ON (B)(6) 2023, IN THE MULTI-PURPOSE INTENSIVE CARE UNIT, IT WAS FOUND THE URINE WAS NOT FLOWING ON A 74 YEAR OLD. THIS INCIDENT CAUSED DISCOMFORT AND PAIN TO THE PATIENT AND PUT THEM AT RISK OF URINARY GLOBES.

    Patient problems: Discomfort; Pain

    MAUDE report 18192723 ↗
  • MalfunctionNov 22, 2023Improper Flow or Infusion; Improper Flow or Infusion

    THE CUSTOMER REPORTED ON 01/11/2023, IN THE MULTI-PURPOSE INTENSIVE CARE UNIT, IT WAS FOUND THE URINE WAS NOT FLOWING ON A 58 YEAR OLD. THIS INCIDENT CAUSED DISCOMFORT AND PAIN TO THE PATIENT AND PUT THEM AT RISK OF URINARY GLOBES.

    Patient problems: Discomfort; Pain

    MAUDE report 18192591 ↗
  • MalfunctionNov 21, 2023Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED THAT THE URINE WASN'T LEAKING. THERE WAS NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT URINE DID NOT FLOW FROM THE TUBE AFTER URINARY CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18187370 ↗
  • MalfunctionNov 16, 2023Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED THAT THE URINE WASN'T LEAKING. THERE WAS NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT URINE DID NOT FLOW FROM THE TUBE AFTER URINARY CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18154782 ↗
  • MalfunctionMay 5, 2023Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED THE NURSES ARE FORCED TO EMPTY THE TUBING EVERY TWO HOURS BECAUSE IT DOESN'T FLOW INTO THE POCKET CAUSING A PROBLEM TO QUANTIFY URINE. THERE WAS NO PATIENT INJURY OR DEATH AND THE TIME OF THE PROCEDURE WAS NOT LONGER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16880485 ↗
  • MalfunctionApr 11, 2023Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED, IF YOU DON'T PUT IT ON THE GROUND, THE URINE STAGNATES IN THE BLADDER AND DOESN'T GO DOWN INTO THE BOX.

    Patient problems: Urinary Retention

    MAUDE report 16712793 ↗
  • MalfunctionAug 11, 2022Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED THAT THE URINE METER DOES NOT DRAIN PROPERLY. THE PATIENT HAS FREQUENT URINARY RETENTION. THE CABINET OF THE URINE METER DOES NOT EMPTY WELL WHEN TILTED. THE BAG PULLS A VACUUM WHICH CAUSES THE CASING NOT TO EMPTY. PER ADDITIONAL INFORMATION PROVIDED ON AUGUST 09, 2022, THIS ISSUE HAS OCCURRED WITH SEVERAL PATIENTS. THE AMOUNT OF URINE RETAINED HAS RANGED FROM 300 TO 500 ML. THE PATIENTS HAVE BEEN TREATED BY BLADDER FLUSHING AND FOLIATION. THERE WERE NO MEDICATIONS PRESCRIBED AS A RESULT OF THE RETENTION AS IT WAS CLEAR THE PROBLEM WAS WITH THE DRAINAGE FROM THE CATHETER. ASSUMING THAT THIS PROBLEM HAS EXISTED FOR SOME TIME, PATIENT'S HAVE DISPLAYED SYMPTOMS OF FEVERS, CHILLS, AND NOT FEELING WELL. ALSO ASSUMING THAT THIS PROBLEM HAS EXISTED FOR SOME TIME, PATIENTS HAVE BEEN RECATHETERIZED, EVEN UP TO THREE TIMES. ON CT, FULL BLADDER, BUT DESCENDING CATHETER. PER ADDITIONAL INFORMATION PROVIDED ON 10AUG2022, FOLIATION IS REFERRING TO THE EMPTYING OF THE BLADDER. IT IS UNKNOWN EXACTLY HOW MANY PATIENTS HAVE BEEN INVOLVED.

    Patient problems: Chills; Fever; Urinary Retention

    MAUDE report 15210717 ↗

Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices

All COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.