Midas Rex MR8 PM800-RRecalls & reported problems
Medtronic Ps Medical, Inc. · MOTOR PM800-R MR8 PNEUMATIC REFURB · Class 2
All models of Midas Rex MR8 (41)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000063962), received between Aug 20, 2024 and Aug 25, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device7
- Noise, Audible2
- Corroded1
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Fluid/Blood Leak
It was reported that the during pre-op the attachment had air/fluid leak. It was reported there was no patient or staff Impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50424370 ↗MalfunctionJun 12, 2026Material Rupture
IT WAS REPORTED THAT THE MOTOR HOSE WAS DAMAGED. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488088 ↗MalfunctionAug 20, 2025Noise, Audible; Noise, Audible
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF NOISE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT DUE TO EVALUATION FINDING OF DETACHED BEARINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22847444 ↗MalfunctionMar 4, 2025Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING AND NOISE. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21512155 ↗MalfunctionFeb 24, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21449003 ↗MalfunctionFeb 24, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT NO PATIENT IMPACT .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21448278 ↗MalfunctionFeb 24, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21448165 ↗MalfunctionFeb 18, 2025Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21392778 ↗MalfunctionNov 11, 2024Overheating of Device; Overheating of Device
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PATIENT OR STAFF IMPACT. REPAIR REQUEST ESCALATED TO A PRODUCT EVENT BASED ON REASON FOR RETURN AND RETURN IN LESS THAN 90 DAYS FROM PURCHASE OR REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20660533 ↗MalfunctionSep 11, 2024Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF CORROSION AND RUSTY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT. REPAIR ESCALATED TO PRODUCT EVENT ON EVALUATION DUE TO DETACHED HOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20187938 ↗MalfunctionAug 20, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE IS OVERHEATING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20004172 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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