MIDAS REX™ AF01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000084714), received between Mar 26, 2020 and Sep 11, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026No Apparent Adverse Event

  Medtronic received information regarding a repair request and no alleged product deficiencies were reported. At the time of the report, there was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726839 ↗
• MalfunctionJun 15, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE ATTACHMENT WITH THE REPORT OF NO REPORTED ISSUE. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25499990 ↗
• MalfunctionMay 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO OUT OF BOX FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016962 ↗
• MalfunctionJul 1, 2022Material Twisted/Bent; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT FOOT BENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. DATE OF EVENT NOTIFICATION - 2022-APR-11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14884102 ↗
• MalfunctionApr 16, 2021Material Puncture/Hole; No Apparent Adverse Event; Material Puncture/Hole; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. UPON EVALUATION, IT WAS NOTED THAT THE LEG OF THE ATTACHMENT WAS BENT. ON FOLLOW-UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT AND PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681831 ↗
• MalfunctionAug 31, 2020Material Puncture/Hole; No Apparent Adverse Event; Material Puncture/Hole; No Apparent Adverse Event

  ON FOLLOW UP, NO FURTHER INFORMATION CAN BE PROVIDED REGARDING THE EVENT, PATIENT IMPACT/STATUS AND TOOL DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10474704 ↗
• MalfunctionMar 26, 2020Material Puncture/Hole; Material Puncture/Hole

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT FOOT BENT / PHYSICAL DAMAGE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9883702 ↗