SP Magnet 3 95773Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09321502028691), received between Sep 22, 2017 and Feb 21, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED ERYTHEMA, SKIN IRRITATION AND TISSUE BREAKDOWN AT THE MAGNET SITE (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Erythema; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 21429522 ↗
• InjuryFeb 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED ERYTHEMA, SKIN IRRITATION AND TISSUE BREAKDOWN AT THE MAGNET SITE (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Erythema; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 21429521 ↗
• InjuryJun 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED AN ULCERATION SKIN BREAKDOWN AT MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL STEROIDS FOR 1 WEEK AND ALTERNATE WITH TOPICAL ANTIBIOTICS FOR 1 WEEK (SPECIFIC DATE NOT REPORTED).

  Patient problems: Tissue Breakdown

  MAUDE report 19481862 ↗
• InjuryJun 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT DEVELOPED AN ULCERATION SKIN BREAKDOWN AT MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL STEROIDS FOR 1 WEEK AND ALTERNATE WITH TOPICAL ANTIBIOTICS FOR 1 WEEK (SPECIFIC DATE NOT REPORTED).

  Patient problems: Tissue Breakdown

  MAUDE report 19481858 ↗
• InjuryMay 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ERYTHEMA AT THE MAGNET SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE SYMPTOMS RESOLVED, AND THE PATIENT RESUMED USE OF THE DEVICE.

  Patient problems: Erythema

  MAUDE report 16990055 ↗
• InjuryApr 27, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN ERYTHEMA AND AN INFECTION AT THE MAGNET SITE WHICH WAS SUCCESSFULLY TREATED WITH A TOPICAL ANTIBIOTIC. THE IMPLANT AND MAGNET REMAIN IN-SITU.

  Patient problems: Erythema; Skin Infection

  MAUDE report 16828563 ↗
• InjuryOct 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE AUDIOLOGIST IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT SKIN BREAKDOWN AT THE MAGNET SITE SUBSEQUENT TO DEVELOPING A PRESSURE SORE AND THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED).

  Patient problems: Erosion; Pressure Sore/Ulcer

  MAUDE report 7982778 ↗
• InjuryMay 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING AND REDNESS AT THE MAGNET SITE. SUBSEQUENTLY THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC FOR A NUMBER OF WEEKS. FOLLOWING TREATMENT THE SYMPTOMS REPORTEDLY RESOLVED.

  Patient problems: Swelling

  MAUDE report 7485904 ↗
• InjurySep 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED AN ULCER AT THE MAGNET SITE. THE PATIENT IS BEING CLINICALLY MANAGED BY THEIR HEALTH CARE PROVIDER.

  Patient problems: Ulcer

  MAUDE report 6885646 ↗

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.