NA 03.045.030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982292674), received between Jan 22, 2025 and Jan 22, 2025 — classified as 1 malfunction.

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

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.

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.

• MalfunctionJan 22, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE EVEN THOUGH THE CONNECTION IS SUPPOSED TO CONNECT, THE CONNECTION WAS BASICALLY LOOSE. THE SALES REP WAS ABLE TO JUST DISCONNECT WITH A PUSH OF HIS THUMB, RATHER THAN USE THE MECHANISM TO DISENGAGE. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21211041 ↗