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MEDLINE DYNDV2580Recalls & reported problems

Medline Industries, Inc. · ULTRASOUND PIV KIT · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10653160359937), received between Apr 23, 2025 and Jun 26, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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

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: 3 reportsMay 2025: 0 reportsJun 2025: 1 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: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Integrity Problem3
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 26, 2025Break; Break

    IT WAS REPORTED THAT "WHEN CONNECTING THE NORMAL SALINE SYRINGE TO THE NEEDLELESS CONNECTOR I NOTICED IT LEAKING" BECAUSE "THE PLASTIC TIP REMAINED IN THE NEEDLELESS CONNECTOR AND COMPRESSED IT SO THE IV WAS JUST BLEEDING BACK."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22341360 ↗
  • MalfunctionApr 24, 2025Material Integrity Problem; Material Integrity Problem

    SALINE SYRINGE SHATTERED OFF OF THE MAIN BARREL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21901590 ↗
  • InjuryApr 24, 2025Material Integrity Problem; Material Integrity Problem

    SYRINGE BROKE WITH FLUSH ATTACHING TO NEEDLELESS CONNECTOR.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 21900233 ↗
  • MalfunctionApr 23, 2025Material Integrity Problem; Material Integrity Problem

    MALE END LEUR LOCK PORTION OF THE SALINE SYRINGE SHATTERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21894477 ↗

Other I.V. start kit devices

All I.V. start kit devices →

Sources and updates

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