SP Magnet 4 95774Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09321502028684), received between Aug 9, 2018 and May 26, 2022 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K131240); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN BREAKDOWN AT THE MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTIC (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Tissue Breakdown

  MAUDE report 14508033 ↗
• InjuryMay 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN BREAKDOWN AT THE MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTIC (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Tissue Breakdown

  MAUDE report 14507791 ↗
• InjuryAug 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION; SUBSEQUENTLY ANTIBIOTICS WERE ADMINISTERED (DATE NOT REPORTED) AND THE MAGNET WAS REPLACED.

  Patient problems: Bacterial Infection

  MAUDE report 7770809 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131240. One submission often covers many models, so check the product and lot details in each record.

• Z-1699-2014 · Apr 9, 2014 · Terminated
  Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.