SURECAN SAFETY II 4447000-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964857737), received between Feb 9, 2022 and Feb 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (2 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.

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.

• MalfunctionFeb 14, 2022Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: "THE NEEDLE COVER WOULD NOT LOCK INTO PLACE RESULTING IN A NURSE GETTING STUCK WITH THE NEEDLE."

  Patient problems: Needle Stick/Puncture

  MAUDE report 13524706 ↗
• MalfunctionFeb 9, 2022Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: "THE NEEDLE COVER WOULD NOT LOCK INTO PLACE RESULTING IN A NURSE GETTING STUCK WITH THE NEEDLE."

  Patient problems: Needle Stick/Puncture

  MAUDE report 13500349 ↗