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Medline SNAPSECURE3WRecalls & reported problems

Medline Industries, Inc. · SNAPSECURE 3-WAY FOLEY DEVICE · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
22
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10193489102710), received between Jul 11, 2024 and Sep 30, 2026 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 16, 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: 6 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: 16 reportsOct 2026: 0 reports20242025202616
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Twisted/Bent6
  • Difficult to Open or Close4
  • Material Integrity Problem4
  • Break3
  • Connection Problem3
  • Material Deformation3
  • Material Split, Cut or Torn3
  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions22

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Difficult to Open or Close

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50948440 ↗
  • MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Twisted/Bent; Material Split, Cut or Torn

    It was reported that "SnapSecure latch and hinge failures"; "Top plastic part is snapping off, some not clamping at all, teeth notch failing."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946719 ↗
  • MalfunctionSep 30, 2026Failure to Align; Material Twisted/Bent

    It was reported that the device ¿un-snaps and won¿t re-snap.¿

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946364 ↗
  • MalfunctionSep 28, 2026Break; Material Deformation; Material Split, Cut or Torn

    It was reported that "Top plastic part is snapping off, some not clamping at all, teeth notch failing.".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50916896 ↗
  • MalfunctionSep 28, 2026Connection Problem

    It was reported that SnapSecure foley securement device will not snap closed; some of them are good, some are bad. The clasps are not fully formed.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50914792 ↗
  • MalfunctionSep 25, 2026Difficult to Open or Close

    It was reported that "Foley Securement Device broken upon removal from package and did not click closed."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50899152 ↗
  • MalfunctionSep 22, 2026Material Twisted/Bent

    It was reported that "During bath, RN changed stat-lock for patient's foley. 2, 3-way Foley attempted, neither would secure closed."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50858605 ↗
  • MalfunctionSep 22, 2026Material Twisted/Bent

    It was reported that Medline SnapSecure foley securement device defect Clamp does not close properly. Multiple packages tried but plastic clamp does not latch and close resulting in catheters not secured to leg.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50855769 ↗
  • MalfunctionSep 21, 2026Failure to Align; Material Deformation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50841084 ↗
  • MalfunctionSep 21, 2026Connection Problem; Difficult to Open or Close

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50838785 ↗
  • MalfunctionSep 19, 2026Difficult to Open or Close

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50832738 ↗
  • MalfunctionSep 18, 2026Loss of or Failure to Bond

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50828791 ↗
  • MalfunctionSep 18, 2026Material Twisted/Bent

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50828658 ↗
  • MalfunctionSep 17, 2026Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50810379 ↗
  • MalfunctionSep 14, 2026Material Twisted/Bent

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50762755 ↗
  • MalfunctionSep 10, 2026Connection Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50722654 ↗
  • InjuryJul 12, 2024Material Integrity Problem; Material Integrity Problem

    ACCORDING TO THE FACILITY ON MULTIPLE DATES, "FAULTY CLASP AND STAT-LOCK IS BREAKING OFF ADHESIVE DRESSING."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19728892 ↗
  • InjuryJul 12, 2024Material Integrity Problem; Material Integrity Problem

    ACCORDING TO THE FACILITY ON MULTIPLE DATES, "FAULTY CLASP AND STAT-LOCK IS BREAKING OFF ADHESIVE DRESSING."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19728886 ↗
  • InjuryJul 12, 2024Material Integrity Problem; Material Integrity Problem

    ACCORDING TO THE FACILITY ON MULTIPLE DATES, "FAULTY CLASP AND STAT-LOCK IS BREAKING OFF ADHESIVE DRESSING."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19728695 ↗
  • InjuryJul 12, 2024Material Integrity Problem; Material Integrity Problem

    ACCORDING TO THE FACILITY ON MULTIPLE DATES, "FAULTY CLASP AND STAT-LOCK IS BREAKING OFF ADHESIVE DRESSING."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19728636 ↗
  • InjuryJul 11, 2024Break; Break

    ACCORDING TO THE FACILITY ON MULTIPLE DATES, FAULTY CLASP AND STAT-LOCK IS BREAKING OFF ADHESIVE DRESSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19727337 ↗
  • InjuryJul 11, 2024Break; Break

    ACCORDING TO THE FACILITY ON MULTIPLE DATES, FAULTY CLASP AND STAT-LOCK IS BREAKING OFF ADHESIVE DRESSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19727323 ↗

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Sources and updates

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