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SYMPHONY 2020-00-116Recalls & reported problems

Medos International Sàrl · SYMPHONY OCT SYSTEM TAP SLEEVE · Class 1

All models of SYMPHONY (113)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034530383), received between Aug 25, 2021 and Aug 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 25, 2021Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TAP SLEEVE WAS FOUND TO BE BROKEN. THE ISSUE WAS DISCOVERED DURING TESTING. THERE WAS NO PATIENT OR SURGICAL IMPACT. THIS REPORT IS FOR ONE TAP SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12366189 ↗

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Sources and updates

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