N/A (REF 7001D)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825008703), received between Nov 21, 2016 and Nov 28, 2016 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Kinked” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 28, 2016Kinked

  IT WAS REPORTED THE DEVICE WAS KINKED INSIDE THE PACKAGING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6128715 ↗
• MalfunctionNov 28, 2016Kinked; Out-Of-Box Failure; Packaging Problem

  IT WAS REPORTED THE DEVICE WAS KINKED INSIDE THE PACKAGING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6128670 ↗
• MalfunctionNov 21, 2016Kinked; Device Damaged Prior to Use; Packaging Problem

  IT WAS REPORTED THE DEVICE WAS KINKED INSIDE THE PACKAGING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6118912 ↗