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Dover 1622Recalls & reported problems

Cardinal Health 200, LLC · 1622G LTX CATH 5CC 2-WAY 22FR · Class 2

All models of Dover (45)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253026177), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Unintended Deflation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2023Unintended Deflation; Unintended Deflation

    THE CUSTOMER REPORTED THAT THE CATHETER WHICH WAS USED AS A SUPRAPUBIC TUBE FELL OUT OF THE PATIENT. THE CATHETER HAD A LEAK IN THE BALLOON. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED ON MARCH 07, 2023 THE PATIENT WAS AN OUTPATIENT AND THE CATHETER WAS REPLACED WITHOUT INCIDENT AFTER IT FELL OUT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16646844 ↗
  • MalfunctionMar 30, 2023Unintended Deflation; Unintended Deflation

    THE CUSTOMER REPORTED THAT THE CATHETER WHICH WAS USED AS A SUPRAPUBIC TUBE FELL OUT OF THE PATIENT SOMETIME DURING THE LAST TWO WEEKS. THE CATHETER HAD A LEAK IN THE BALLOON. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16646484 ↗
  • InjuryMar 30, 2023Unintended Deflation; Unintended Deflation

    THE CUSTOMER REPORTED THAT THE FOLEY CATHETER, WHICH WAS BEING USED AS AN SUPRAPUBIC (SP) TUBE, FELL OUT OF THE PATIENT. IT HAD A LEAK IN THE BALLOON. THE PATIENT HAD TO GO BACK TO THE OR TO HAVE AN SP TUBE REPLACED. PER ADDITIONAL INFORMATION PROVIDED ON MARCH 07, 2023, THE INCIDENT OCCURRED 5-6 MONTHS AGO. THE PATIENT RETURNED TO THE OR BECAUSE THE SUPRAPUBIC TUBE TRACT CLOSED OFF AFTER THE TUBE FELL OUT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16645177 ↗

Other CATHETER, UROLOGICAL devices

All CATHETER, UROLOGICAL devices →

Sources and updates

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