MEDLINE DYNJ68937ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489111545), received between Jan 13, 2022 and Sep 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. May 18, 2023Open, Classified

   Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

   Z-2200-2023 · Root cause: Device Design · Recall details · FDA record ↗

2. May 15, 2023Open, Classified

   Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

   Z-2323-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Twisted/Bent

  It was reported that ¿It kinda coiled up. Like if you were to smash a straw down, what the tip would look like. The dilator had a lot of resistance.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896095 ↗
• MalfunctionJan 13, 2022Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER KINKED AND THE ACCOUNT WAS UNABLE TO FLUSH THE DEVICE OR OBTAIN ANY BLOOD RETURN WHICH REQUIRED CATHER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253766 ↗