NA 03.010.087Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982067579), received between Jan 16, 2019 and Oct 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 12, 2022Material Integrity Problem; Material Integrity Problem

  NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588555 ↗
• MalfunctionJan 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2018 DURING THE SURGERY, THE 2.0 GUIDE WIRE WOULD NOT PASS THROUGH THE 8.0MM/2.0MM WIRE GUIDE 140MM. IT WAS CONFIRMED THAT THE CORRECT WIRE AND WIRE GUIDE WERE BEING USED. ADDITIONALLY, THE SET WAS INSPECTED ON (B)(6) 2018 PRIOR TO THE SURGERY. IT IS NOT SURE IF IT WAS BIO BURDEN OR DAMAGE TO THE 8.0MM/2.0MM WIRE SLEEVE. THERE WAS A MINIMAL SURGICAL DELAY OF APPROXIMATELY MINUTE OR TWO MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AVAILABLE ALTERNATE DEVICES. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) 8.0MM/2.0MM WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8252670 ↗