FEI 1625507
Medtronic Powered Surgical Solutions
4620 NORTH BEACH ST., FORT WORTH, TX, US
MDR events507All time
Recalls2All time
Registered products15
Establishment typeManufactureManufacture Medical Device
Registered product codes
15 product codes
Recent MDR events
507 on file
- MIDAS REX MR8Jan 29, 2026Malfunction24208146
- MIDAS REX MR8Jan 8, 2026Malfunction24002612
- MIDAS REXDec 15, 2025Malfunction23802679
- MR8 ELECTRIC DRILLJun 26, 2025MalfunctionMW5172011
- MR8 ELECTRIC DRILLJun 26, 2025MalfunctionMW5172012
- MIDAS REX MR8 DRILLMay 21, 2025Malfunction22060021
- MIDAS REX 8 NAVIGATIONAL STEALTHMay 20, 2025InjuryMW5170612
- MEDTRONIC MIDAS REX STYLUS MIDAS REX STYLUSMay 16, 2025InjuryMW5170463
- MEDTRONIC MIDAS REX STYLUS MIDAS REX STYLUSMay 16, 2025InjuryMW5170464
- MEDTRONIC MIDAS REX 8May 16, 2025InjuryMW5170526
Recalls
2 on file
- TerminatedAug 23, 2008
Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
View FDA record ↗ - TerminatedAug 3, 2005
Complaints of finger control component breaking off and falling into open surgical wound.
View FDA record ↗
Compliance history
Matched by FEI 1625507.
FDA inspections
2 on file
- No Action Indicated (NAI)Dec 5, 2024
Compliance: Devices
- No Action Indicated (NAI)Dec 5, 2024
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.