NA 72200872SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556582411), received between Dec 19, 2017 and Apr 26, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2018Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS RUNNING HOT. NEITHER DELAY NOR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7465501 ↗
• MalfunctionJan 16, 2018Overheating of Device

  IT WAS REPORTED THAT THE MDU WAS OVERHEATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7194234 ↗
• MalfunctionDec 19, 2017Overheating of Device

  IT WAS REPORTED THAT THE MDU WAS GETTING HOT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129888 ↗