Dover PP16CSDRecalls & reported problems
Cardinal Health 200, LLC · 100% SILICONE FOLEY TRAY, COUDE TIP, LL, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CATH SECURE · 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 10884521143364), received between Nov 30, 2023 and Nov 30, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Deflation” (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.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON BURST ALMOST IMMEDIATELY AFTER INSERTING THE CATHETER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18238905 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.