HOFFMANN 4933-1-530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252610465), received between Feb 12, 2026 and Feb 13, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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. 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.

• InjuryFeb 13, 2026Fracture

  AS REPORTED: RING BROKE ON HLRF FRAME IN PATIENT HOME. THE PATIENT NOTICED A NOISE ON CHRISTMAS EVE AND THEN ATTENDED CLINIC ON NEW YEAR'S EVE FOR REVIEW. DECISION REMAINS OUTSTANDING AS TO WHETHER OR NOT PATIENT WILL BE REVISED (ADVERSE CONSEQUENCES). 01/16/2026 - TWO ADDITIONAL DEVICES WERE RECEIVED UPON PRODUCT RETURN. BOTH DEVICES ARE BROKEN AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 24332351 ↗
• InjuryFeb 12, 2026Fracture

  AS REPORTED: RING BROKE ON HLRF FRAME IN PATIENT HOME. THE PATIENT NOTICED A NOISE ON CHRISTMAS EVE AND THEN ATTENDED CLINIC ON NEW YEAR'S EVE FOR REVIEW. DECISION REMAINS OUTSTANDING AS TO WHETHER OR NOT PATIENT WILL BE REVISED (ADVERSE CONSEQUENCES). 01/16/2026 - TWO ADDITIONAL DEVICES WERE RECEIVED UPON PRODUCT RETURN. BOTH DEVICES ARE BROKEN AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 24324538 ↗