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
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
- Medline Industries, Inc. CDS860014PMedline Industries, Inc. · I.V. start kit3 recalls0 reports
- Medline Industries, Inc. DYKM1000BMedline Industries, Inc. · I.V. start kit3 recalls0 reports
- MEDLINE DYNJ68937AMedline Industries, Inc. · I.V. start kit2 recalls2 reports
- Centurion IVS3940BCenturion Medical Products Corporation · I.V. start kit2 recalls0 reports
- Centurion CVI3650Centurion Medical Products Corporation · I.V. start kit2 recalls0 reports
- MEDLINE DYNDV2465Medline Industries, Inc. · I.V. start kit2 recalls0 reports
- MEDLINE PICC0010Medline Industries, Inc. · I.V. start kit2 recalls0 reports
- Centurion IVS3900ACenturion Medical Products Corporation · I.V. start kit2 recalls0 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.
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