SP Magnet 1 95771Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09321502028714), received between Nov 28, 2024 and Nov 28, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2024Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A SWELLING AND AN INFECTION (SITE OF INFECTION NOT CONFIRMED). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Purulent Discharge; Skin Infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 20803369 ↗
• InjuryNov 28, 2024Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  CORRECTION : PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING AND AN INFECTION WHICH LEADS TO PUS AT THE MAGNET SITE (DATE NOT REPORTED). PER THE CLINIC, IT WAS ALSO REPORTED THAT THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND TOPICAL STEROID (SPECIFIC DATE AND DURATION NOT REPORTED).

  Patient problems: Purulent Discharge; Skin Infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 20803368 ↗

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.