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Medline SNAPSECURERecalls & reported problems

Medline Industries, Inc. · SNAPSECURE FOLEY DEVICE · Class 1

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10193489010466), received between Sep 14, 2026 and Sep 30, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 7 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Difficult to Open or Close1
  • Loose or Intermittent Connection1
  • Material Split, Cut or Torn1
  • Material Twisted/Bent1
  • Sharp Edges1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6
  • Insufficient Information1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Material Split, Cut or Torn

    It was reported that "IN THE LAST MONTH HE HAS WENT THROUGH 5 THAT HAS WENT BAD! THE SECUREMENT DEVICE THAT HE IS USING IS DEFECTIVE-STATED THAT THE BASE PLATE OF THE SECUREMENT IS COMING APART-"

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948644 ↗
  • MalfunctionSep 30, 2026Detachment of Device or Device Component

    It was reported that "The lockdown pops off".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946387 ↗
  • MalfunctionSep 30, 2026Detachment of Device or Device Component

    It was reported that Stat lock became disconnected from base and was no longer supporting catheter.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50945937 ↗
  • MalfunctionSep 29, 2026Material Twisted/Bent

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50936092 ↗
  • MalfunctionSep 23, 2026Difficult to Open or Close

    It was reported that Medline Foley catheter securement device would not re-clasp after adjusting Foley catheter.

    Patient problems: Insufficient Information

    MAUDE report 50867241 ↗
  • MalfunctionSep 23, 2026Sharp Edges

    It was reported that "one of Medline's devices, the Snapsecure Foley Securement Device has 4 sharp prongs that puncture the Foley catheter causing it to leak." "The prongs inside of the clip were definitely too sharp to be used with any plastic or rubber material as our foley catheters were."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50866861 ↗
  • MalfunctionSep 14, 2026Loose or Intermittent Connection

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50747967 ↗

Other HOLDER, URETERAL CATHETER devices

All HOLDER, URETERAL CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.