Medline DYND11758Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,SILI-ELAST,LTX,18FR,10ML · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196726530), received between Apr 19, 2018 and Jun 17, 2026 — classified as 5 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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. 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
- Inflation Problem3
- Failure to Deflate2
- Adverse Event Without Identified Device or Use Problem1
- Burst Container or Vessel1
- Deflation Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
- Foreign Body In Patient1
- Urinary Tract Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Failure to Deflate
IT WAS REPORTED THAT BALLOONS WERE NOT FULLING DEFLATING INSIDE PATIENT'S BLADDER.
Patient problems: Insufficient Information
MAUDE report 25540726 ↗MalfunctionJul 29, 2025Inflation Problem; Inflation Problem
DEFECTIVE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22648587 ↗InjuryJul 28, 2025Inflation Problem; Inflation Problem
ACCORDING TO THE CUSTOMER, THE INDWELLING CATHETER FROM HIS LAST TWO ORDERS HAD "DEFECTIVE BALLOONS" AND THAT THE CATHETERS HAD TO BE REPLACED AT HIS DOCTOR'S OFFICE TO COMPLETE HIS EXCHANGE.
Patient problems: Insufficient Information
MAUDE report 22631133 ↗InjuryJul 14, 2025Deflation Problem; Failure to Deflate; Deflation Problem; Failure to Deflate
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, DURING A ROUTINE FOLEY CATHETER CHANGE AT THE 30-DAY MARK, THE "CATHETER BALLOON WOULD NOT DEFLATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494816 ↗MalfunctionJun 27, 2025Inflation Problem; Inflation Problem
BALLOON WOULD NOT DEFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345344 ↗InjuryJul 3, 2024Material Rupture; Material Rupture
ACCORDING TO THE REPORT RECEIVED ON 05/15/2024 "THE BALLOON LUMEN RUPTURED 12 HOURS AFTER INSERTION LEADING TO SUBSEQUENT DISLODGEMENT, PATIENT SELF-REINSERTED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667523 ↗InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE END-USER THAT THE CATHETER IS CAUSING BLEEDING AROUND THE CATHETER SITE AND URINARY TRACT INFECTIONS (UTIS).
Patient problems: Urinary Tract Infection
MAUDE report 13049614 ↗InjuryApr 19, 2018Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER "EXPLODED."
Patient problems: Foreign Body In Patient
MAUDE report 7442927 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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