Medline DYND11502Recalls & reported problems
Medline Industries, Inc. · CATHETER,FOLEY,100%SILICONE,16FR,10ML,LF · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medline silicone Foley retention catheter, a balloon-type catheter used to drain the bladder. The 45 reports mostly describe the balloon losing air or bursting, so the catheter slips out of the patient, along with some bleeding and tissue irritation. 19 reports mention injuries and no deaths. No recalls name this device, and report numbers are steady.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884389034538), received between Feb 12, 2019 and Sep 8, 2026 — classified as 19 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (9 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
- Material Rupture9
- Appropriate Device Problem Term/Code Not Available8
- Fluid/Blood Leak7
- Material Integrity Problem6
- Device Dislodged or Dislocated5
- Device Fell5
- Unintended Deflation5
- Inflation Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Genital Bleeding3
- Tissue Irritation2
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673481 ↗MalfunctionSep 8, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670044 ↗MalfunctionSep 7, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658751 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
It was reported that "THEY HAVE BEEN LEAKING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551796 ↗MalfunctionJun 25, 2026Collapse
IT WAS REPORTED THAT "THEY'VE HAD THE CATHETER FALL OUT OF PATIENTS DUE TO THE BALLOON COLLAPSING."
Patient problems: Insufficient Information
MAUDE report 25627041 ↗MalfunctionJun 18, 2026Deflation Problem; Unintended Deflation
IT WAS REPORTED THAT, "THE BALLOON WAS DEFLATING WITH WARNING" AND THAT THE EVENT OCCURRED "3 TIMES IN ONE WEEK," REQUIRING "ADDITIONAL NURSING VISITS TO REPLACE THE FOLEY CATHETER AND THIS WAS REPEATED 3 TIMES."
Patient problems: Genital Bleeding; Tissue Irritation
MAUDE report 25554482 ↗MalfunctionJun 18, 2026Unintended Deflation
IT WAS REPORTED THAT "THE BALLON WAS DEFLATING WITH WARNING" AND THAT THE EVENT OCCURRED "3 TIMES IN ONE WEEK," REQUIRING "ADDITIONAL NURSING VISITS TO REPLACE THE FOLEY CATHETER AND THIS WAS REPEATED 3 TIMES."
Patient problems: Genital Bleeding; Tissue Irritation
MAUDE report 25553318 ↗MalfunctionJun 18, 2026Inflation Problem; Unintended Deflation
"FOLEY CATHETER HAS COME OUT DUE TO THE BALLOON INFLATING."
Patient problems: Genital Bleeding
MAUDE report 25553308 ↗MalfunctionApr 29, 2026Break
CLIENT REPORTS, "HE IS HAVING DIFFICULTY WITH HIS CATHETERS. THE BALLOON "FARTS" AND HE HAS TO REPLACE THE CATHETER FASTER THAN USUAL." THE CUSTOMER FURTHER STATED, "THE BALLOON BURST."
Patient problems: Insufficient Information
MAUDE report 25035121 ↗MalfunctionJan 21, 2026Inflation Problem
BALLOON OF CATHETER DEFLATED CAUSING IT TO FALL OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136075 ↗MalfunctionJan 21, 2026Inflation Problem
BALLOON OF CATHETER DEFLATED CAUSING IT TO FALL OUT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24131674 ↗MalfunctionDec 29, 2025Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem
ACCORDING TO THE FACILITY, ON (B)(6) 2025, 5 DAYS AFTER A ROUTINE CATHETER CHANGE, THE PATIENT "PRESENTED TO THE ER STATING THAT THE PREVIOUS DAY SHE FELT A POP AND HER CATHETER FELL OUT SHORTLY THEREAFTER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23915431 ↗InjurySep 5, 2025Inflation Problem; Inflation Problem
"FOLEY CATHETER BALLOON DEFLATED AND FELL OUT POST CATHERIZATION."
Patient problems: Insufficient Information
MAUDE report 22977955 ↗InjuryMay 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE CATHETER DISLODGED REQUIRING A NEW CATHETER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119499 ↗InjuryMay 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE CATHETER DISLODGED REQUIRING A NEW CATHETER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119301 ↗InjuryMay 27, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
FOLEY CATHETER WOULD NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089935 ↗InjuryMay 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 THE CATHETER DISLODGED REQUIRING A NEW CATHETER INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055370 ↗InjuryApr 21, 2025Material Rupture; Material Rupture
ACCORDING TO THE REPORT, THE FOLEY BALLOON "RUPTURED" INSIDE THE PATIENT WHILE BEING USED AS A "SUPRAPUBIC CATHETER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21875248 ↗InjuryApr 18, 2025Material Integrity Problem; Material Integrity Problem
BALLOON RUPTURED INSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21865703 ↗InjuryMay 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE BALLOON DEFLATED WHILE IN PLACE IN A PATIENT REQUIRING THE FOLEY CATHETER TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19287323 ↗InjuryMay 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE BALLOON DEFLATED WHILE IN PLACE IN A PATIENT REQUIRING THE FOLEY CATHETER TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19286910 ↗InjuryFeb 26, 2024Obstruction of Flow; Obstruction of Flow
CLOGGING OF CATHETER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18782638 ↗InjuryJan 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER THE BALLOON BURST REQUIRING THE FOLEY CATHETER TO BE REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18494109 ↗MalfunctionJan 10, 2024Material Integrity Problem; Material Integrity Problem
FOLEY BALLOON BURST INSIDE THE PATIENT AND STARTED LEAKING.
Patient problems: Insufficient Information
MAUDE report 18485798 ↗MalfunctionJan 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
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.
How reports and recalls are matched · Editorial policy · Report an error on this page