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Dover PP16XSDRecalls & reported problems

Cardinal Health 200, LLC · 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2-WAY, CATH SECUREMENT · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521029705), received between Oct 26, 2020 and Oct 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Deflation Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 26, 2020Deflation Problem; Deflation Problem

    THE CUSTOMER REPORTED THAT WHEN ALL THE WATER WAS REMOVED FROM THE BALLOON, THE BALLOON OF THE FOLEY DIDN'T DEFLATE COMPLETELY. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER AND IT WAS STATED THAT THE ISSUE WAS IDENTIFIED AFTER THE PROCEDURE, THERE WAS NO DELAY IN THE PROCEDURE AND NO SECOND DEVICE WAS USED. THE CUSTOMER FURTHER CONFIRMED THAT THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10733754 ↗

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

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