Midas Rex MR8 MR8-AF01 (UDI 00643169912397)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169912397), received between Jul 1, 2022 and Jun 26, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Naturally Worn

  IT IS REPORTED THAT THE DEVICE BEARING BROKEN. IT IS REPORTED THAT THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25634363 ↗
• MalfunctionJun 19, 2026Overheating of Device

  IT WAS REPORTED THAT PRIOR TO USE THE DEVICE HAD TEMPERATURE INCREASE ISSUE. THERE WAS NO PATIENT IMPACT REPORTED.  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT CHIPPED DISTAL BEARING WAS FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561757 ↗
• MalfunctionJun 18, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A REPAIR REQUEST, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DETACHED BEARINGS WERE FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546531 ↗
• MalfunctionJun 10, 2026Overheating of Device

  IT WAS REPORTED THAT, PRIOR TO USE, THE DEVICE WAS OBSERVED TO HAVE A TEMPERATURE INCREASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456469 ↗
• MalfunctionJun 1, 2026No Apparent Adverse Event

  MEDTRONIC RECEIVED INFORMATION REGARDING A SCHEDULED PREVENTIVE MAINTENANCE, AND NO ALLEGED PRODUCT DEFICIENCIES WERE REPORTED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DISTAL BEARINGS WERE DETACHED, TIP OF THE TUBE IS OUT OF SHAPE, LASER MARKINGS AND COLOR BAND WERE FOUND FADED DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355227 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BEARING WERE FELL OUT DURING A PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DISTAL BEARING WAS DETACHED WERE FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328453 ↗
• MalfunctionMay 19, 2026Vibration; Detachment of Device or Device Component; Naturally Worn; Noise, Audible

  IT WAS REPORTED THAT THE BEARINGS WERE BAD, LOUD AND ¿RUNNING ROUGH¿. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222359 ↗
• MalfunctionMar 31, 2026Overheating of Device

  IT WAS REPORTED THAT PRE-OPERATIVELY THERE WAS TEMPERATURE INCREASE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744160 ↗
• MalfunctionAug 6, 2024Material Twisted/Bent; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BENT FOOT. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921459 ↗
• MalfunctionAug 6, 2024Material Twisted/Bent; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF BENT FOOT. NO PATIENT IMPACT REPORTED. REPAIR IS BEING ESCALATED TO PRODUCT EVENT DUE TO REASON FOR THE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915663 ↗
• MalfunctionApr 12, 2023Electrical /Electronic Property Problem; Material Twisted/Bent; Electrical /Electronic Property Problem; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF FROZEN. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO LEG OF THE ATTACHMENT WAS BENT. ON FOLLOW UP IT WAS REPORTED THAT THERE IS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723082 ↗
• MalfunctionNov 22, 2022Material Twisted/Bent; No Apparent Adverse Event; Material Twisted/Bent; No Apparent Adverse Event

  REPAIR REQUEST INITIATED FOR DEVICE WITH NO REPORTED MALFUNCTION. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO LEG OF THE ATTACHMENT WAS BENT. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. DATE OF EVENT NOTIFICATION: ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842670 ↗
• MalfunctionJul 1, 2022Material Twisted/Bent; Material Twisted/Bent

  REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF ATTACHMENT DAMAGED OR BENT LEG. NO PATIENT IMPACT WAS REPORTED. REPAIR ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN. ADDITIONAL INFORMATION REGARDING THE PATIENT IMPACT WAS BEING FOLLOWED UP FROM THE FACILITY. DATE OF EVENT NOTIFICATION: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883435 ↗