NA 610410Recalls & reported problems
B Braun Interventional Systems, Inc · 018 X 40 GUIDEWIRE NIT WIRE-PT TIP · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964328121), received between Feb 25, 2021 and Feb 25, 2021 — classified as 1 injury.
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
Device problems
- Break1
- Entrapment of Device1
- Failure to Advance1
- Material Frayed1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2021Break; Entrapment of Device; Material Frayed; Failure to Advance
AS RECEIVED FROM END USER-CUSTOMER (GUIDEWIRE BROKE OFF UPON PLACEMENT IN IJ. UPON ATTEMPT TO INSERT WIRE WAS NOT ADVANCING, PULLED BACK AND END OF WIRE WAS FREAYED AND TIP MISSING. RETAINED IN PATIENT. PATIENT OUTCOME, RELATED TO EVENT: NO HARM).
Patient problems: Foreign Body In Patient
MAUDE report 11382071 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.