MEDLINE ECVC8130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653160358343), received between Mar 20, 2024 and Sep 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 FDA recall record name this device's identifier, 1 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 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Biocompatibility

  It was reported that "fed the guide wire through the access needle, couldn¿t retract the wire from the needle. Had to pull needle and wire, the curved portion of the wire would push past the needle but not pull into the tip of the access needle."

  Patient problems: Insufficient Information

  MAUDE report 50885031 ↗
• MalfunctionMar 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, THEY "PLACED THE 16 CM LINE, NEEDED TO RETRACT AND LOOP, AND THE LINE KINKED TWICE AT THE NUMBERS END NEAR ~13- 15 CM HASH.

  Patient problems: Insufficient Information

  MAUDE report 18944203 ↗