NA 395.902Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982200884), received between Nov 1, 2019 and Aug 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CHECKING A WIRE GUIDE, THE 1.25 WIRE DID NOT GO THROUGH THE GUIDE SMOOTHLY AND WAS ROUGH. THE GUIDE MAY BE DAMAGED AND NEED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE 1.25MM/1.6MM PROTECTION SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611784 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION THE LOANER DEPARTMENT FOUND THE PROTECTION SLEEVE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVED ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268190 ↗