MEDLINE ECVC4335Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160357285), received between Feb 27, 2023 and Feb 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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. How this data works · Data updated Oct 13, 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-2194-2023 · Root cause: Device Design · FDA record ↗

2. May 15, 2023Open, Classified

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

   Z-2297-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 WHEN ATTEMPTING TO INSERT A CENTRAL LINE INTO THE "RIGHT IJ" THE INTRODUCER WAS NOTED TO HAVE "A HOLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448403 ↗