McKesson 16-LFOL520CRecalls & reported problems
Mckesson Medical-Surgical Inc. · CATHETER, FOLEY COUDE TIP LATEX 16" 20FR 5-15CC · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10612479246987), received between Jan 3, 2025 and Dec 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove2
Patient problems
- Insufficient Information1
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED BY THE CUSTOMER THAT CATHETER WAS DIFFICULT TO REMOVE. BALLOON DID DEFLATE TO REMOVE. PATIENT EXPERIENCED BLEEDING DURING REMOVAL.
Patient problems: Unspecified Kidney or Urinary Problem
MAUDE report 23863798 ↗InjuryJan 3, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED BY THE CUSTOMER THAT PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE THE CATHETER COULD NOT BE REMOVED. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED OTHER THAN THE PATIENT WENT TO THE HOSPITAL.
Patient problems: Insufficient Information
MAUDE report 21071642 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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