Dover 1616 (UDI 10192253026146)Recalls & reported problems
Cardinal Health 200, LLC · HYDROGEL COATED LATEX FOLEY CATHETER, 5 CC, 2-WAY, 16 FR (5.3 MM) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253026146), received between Nov 27, 2023 and Sep 12, 2024 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
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.
MalfunctionSep 12, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT URINE LEAKED DURING THE CATHETER BEING USED WITH A PRODUCT THAT WAS NOT A NON-CARDINAL PRODUCT. AFTER REVIEW OF THE INVESTIGATION ON AUGUST 26, 2024, IT WAS FOUND THAT THE SAMPLE RECEIVED HAS A PINHOLE AT THE BALLOON EDGE AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20201994 ↗MalfunctionJul 24, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT A PINHOLE WAS FOUND DURING THE BALLOON TEST PRIOR TO USE. THERE WAS NO PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19819213 ↗MalfunctionNov 27, 2023Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT DURING USE, A LEAK OCCURRED FROM THE BALLOON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18212099 ↗
Other CATHETER, UROLOGICAL devices
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- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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