Dover 3607Recalls & reported problems
Cardinal Health 200, LLC · SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 18 FR (6.0 MM) · Class 2
All models of Dover (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10192253026436), received between Nov 3, 2025 and Nov 3, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE CERVICAL FOLEY BURST WHEN INFLATING INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT IT WAS UNSURE IF THE BALLOON WAS RUPTURED WITH A PINHOLE OR LEAK. THE PATIENT DESCRIBED THE FEELING AS THE BALLOON HAVING¿ ¿BURST¿. ACCORDING TO THE CUSTOMER, THE BALLOON HAD A CLEAN TEAR AND IN ONE PIECE, THOUGH IT WAS FULLY DEFLATED. THERE WAS NO TREATMENT NEEDED AND THERE WAS NO PATIENT INJURY. THEY HAD TO RE-INSERT THE CATHETER WHICH CAUSED UNNECESSARY DISCOMFORT TO THE PATIENT INVOLVED.
Patient problems: Discomfort
MAUDE report 23453712 ↗
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- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
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- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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