Midas Rex MR8 PM800 (UDI 00643169912137)Recalls & reported problems
Medtronic Powered Surgical Solutions · MOTOR PM800 MR8 PNEUMATIC · Class 2
All models of MIDAS REX MR8 (137)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169912137), received between Nov 28, 2024 and May 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Loss of Power1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Fluid/Blood Leak; Material Rupture
IT WAS REPORTED PRE-OPERATIVELY THAT THE HOSE WAS LEAKING. THERE WAS NO KNOWN PATIENT IMPACT OR INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244134 ↗MalfunctionNov 28, 2024Loss of Power; Detachment of Device or Device Component; Loss of Power; Detachment of Device or Device Component
REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF STOPS WORKING. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. REPAIR REQUEST ESCALATED TO PRODUCT EVENT DUE TO CUSTOMER INDICATION THAT THIS REPORT IS A COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20804910 ↗
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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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