NA 0400850000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540904508), received between Jul 23, 2019 and Oct 28, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 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.

• MalfunctionOct 28, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9245088 ↗
• MalfunctionJul 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8816153 ↗