ACUFEX 7205525Recalls & reported problems
Smith & Nephew, Inc. · ACUFEX DIRECTOR 4-POINT BULLET · Class 1
All models of ACUFEX (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010373243), received between Jun 18, 2020 and Jun 18, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (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
Device problems
- Illegible Information2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2020Illegible Information; Illegible Information
IT WAS REPORTED THE 4 POINT DIRECTOR HAD THE CALIBRATION MARKS NO LONGER LEGIBLE. THERE IS NOT A CASE REPORTED BUT THIS HAS BEEN AN ONGOING ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Information
MAUDE report 10170241 ↗MalfunctionJun 18, 2020Illegible Information; Illegible Information
IT WAS REPORTED THE 4 POINT DIRECTOR HAD THE CALIBRATION MARKS NO LONGER LEGIBLE. THERE IS NOT A CASE REPORTED BUT THIS HAS BEEN AN ONGOING ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Information
MAUDE report 10168856 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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