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EXPEDIUM 2797-22-940Recalls & reported problems

Medos International Sàrl · EXPEDIUM Advance Derotation Tube · Class 1

All models of EXPEDIUM (291)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034507934), received between Mar 22, 2021 and Mar 23, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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

Device problems

  • Device-Device Incompatibility6
  • No Apparent Adverse Event3

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE (3) DEROTATION TUBES WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DEROTATION TUBE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11554030 ↗
  • MalfunctionMar 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE (3) DEROTATION TUBES WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DEROTATION TUBE. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11553933 ↗
  • MalfunctionMar 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREE (3) DEROTATION TUBES WERE NOT WORKING PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DEROTATION TUBE. THIS IS REPORT 1 OF 3 FOR PC (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11553902 ↗
  • MalfunctionMar 22, 2021Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

    THESE PRODUCTS WERE NOT USED IN SURGERY, THEY WERE DISCOVERED DURING AN INSPECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11547773 ↗
  • MalfunctionMar 22, 2021Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

    THESE PRODUCTS WERE NOT USED IN SURGERY, THEY WERE DISCOVERED DURING AN INSPECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11547757 ↗
  • MalfunctionMar 22, 2021Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

    THESE PRODUCTS WERE NOT USED IN SURGERY, THEY WERE DISCOVERED DURING AN INSPECTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11547724 ↗

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Sources and updates

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