Dover 6950Recalls & reported problems
Cardinal Health, Inc. · 100% Silicone Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Slip Sampling · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521154299), received between Jan 30, 2024 and Jan 30, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Deflation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Deflation2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Sepsis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON HAS BUSTED AND CAUSED ISSUES OVER THE LAST YEAR. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2024 STATED HE HAS BEEN USING THIS PRODUCT FOR 5 YEARS AND HAS NOT HAD ANY ISSUES WITH THE PRODUCT UNTIL THE LAST YEAR WITH BALLOONS DEFLATING FOR NO KNOWN REASON. SOME OF THE BALLOONS DEFLATED AFTER ONLY 5 HOURS, OTHERS AFTER 2 WEEKS. HE DID NOT LOG THE DATES OF ANY OF THE INCIDENTS. THE LOT NUMBERS ARE NOT KNOWN. HE ONLY USES THE LUBRICANT FROM THE KIT, NO EXTERNAL PRODUCTS WERE USED DURING INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18610866 ↗InjuryJan 30, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE BALLOON HAS BUSTED AND CAUSED ISSUES. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6)2024 STATED THE CATHETER BALLOON DEFLATED CAUSING HIM TO DEVELOP SEPSIS. THIS OCCURRED AROUND (B)(6) 2023. EXACT DATE UNKNOWN. HE WAS TAKEN TO THE HOSPITAL VIA AMBULANCE AS HE DOES NOT DRIVE DUE TO HIS MULTIPLE SCLEROSIS DIAGNOSIS. HE WAS ADMITTED FOR ABOUT A WEEK AND WAS ON AN ANTIBIOTIC. THE NAME OF THE ANTIBIOTIC IS UNKNOWN. HE STATED THE INFECTION WAS RELATED TO THE BALLOON DEFLATING. HE WAS TOLD HE IS NOW MORE SUSCEPTIBLE TO INFECTIONS. HE STATED HE HAS BEEN USING THE DOVER FOLEYS FOR 5 YEARS AND DID NOT HAVE A PROBLEM UNTIL LAST YEAR. HE CONFIRMED THAT HE ONLY USES THE LUBRICANT FROM THE KIT, NO OTHER PRODUCTS ARE USED.
Patient problems: Sepsis
MAUDE report 18610862 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
- Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber 802001C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER117 reports
- Bard® Urinary Drainage Bag with Anti-Reflux Chamber 154002C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153214AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153204C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.