Dover 1512CRecalls & reported problems
Cardinal Health, Inc. · Hydrogel Coated Latex Foley Catheter,Coude Tip, 5 mL, 2-Way, Red · Class 2
All models of Dover (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521016040), received between Sep 28, 2023 and May 2, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (2 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.
Reports received per month
Most reported problems
Device problems
- Failure to Deflate2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate
THE CUSTOMER REPORTED THAT THE PATIENT CAME TO UNC LENOIR. A FOLEY CATHETER WAS INSERTED, AFTER LEVSIN SL WAS GIVEN. THE PATIENT STARTED COMPLAINING OF PAIN SO THEY STOPPED INFLATING BALLOON AND TRIED TO DEFLATE THE BALLOON, AND STARTED DISCONTINUING FOLEY AND REALIZED THE BALLOON STILL HAD STERILE WATER IN PLACE. THEY TRIED DIFFERENT TECHNIQUES TO DEFLATE THE BALLOON AND NOTHING WORKED. THEY CALLED THE PHYSICIAN AND INFORMED THEM OF WHAT HAPPENED. THE PHYSICIAN INSTRUCTED THEM TO LEAVE THE FOLEY IN PLACE AND CLAMP IT AND SEND THE PATIENT TO HIS OFFICE. THE PHYSICIAN USED AN ULTRASOUND TO REMOVE THE FOLEY. THEN THEY RESCHEDULED FOR 2 WEEKS FOR NEXT TREATMENT. THEY ARE CONCERNED THE 12 FR COUDE CATHETER MALFUNCTIONED.
Patient problems: Pain
MAUDE report 19233663 ↗MalfunctionSep 28, 2023Failure to Deflate; Failure to Deflate
THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH A FAULTY CATHETER BALLOON ON 5E. THE NURSE TESTED THE BALLOON PRIOR TO INSERTION AND IT WORKED FINE. HOWEVER, AFTER IT WAS INSERTED THEY COULD NOT GET THE BALLOON TO COMPLETELY DEFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17835694 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
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- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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