Midas Rex Clearview™ SP14MH30TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169308411), received between Mar 5, 2020 and Mar 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081277); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE UNIT WAS BRAND NEW AND OPENED FROM THE STERILE PACK FOR THE CASE. THE PRODUCT WAS USED FOR APPROXIMATELY 5-10 MINUTES OF INTERMITTENT USE. THERE WERE NO ANATOMICAL VARIANCES OR UNEXPECTED DIFFICULTIES THAT MAY HAVE CONTRIBUTED TO THE BREAK. THERE WAS NO IRRIGATION BEING USED. THE UNIT WAS USED ON A NORMAL FORWARD MODE SET AT 60,000 RPM. THE PATIENT WAS WELL AND IN GOOD HEALTH CURRENTLY. ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE UNIT WAS BRAND NEW AND OPENED FROM THE STERILE PACK FOR THE CASE. THE PRODUCT WAS USED FOR APPROXIMATELY 5-10 MINUTES OF INTERMITTENT USE. THERE WERE NO ANATOMICAL VARIANCES OR UNEXPECTED DIFFICULTIES THAT MAY HAVE CONTRIBUTED TO THE BREAK. THERE WAS NO IRRIGATION BEING USED. THE UNIT WAS USED ON A NORMAL FORWARD MODE SET AT 60,000 RPM. THE PATIENT WAS WELL AND IN GOOD HEALTH CURRENTLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9794407 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E