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Tango M2 99-0088-15Recalls & reported problems

Suntech Medical, Inc. · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840935105732), received between Aug 9, 2021 and Aug 9, 2021 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • DeathAug 9, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    HILL ROM REPORTED TO SUNTECH THAT A PATIENT DIED WHILE UNDERGOING A STRESS TEST. THE HILL ROM STRESS TEST SYSTEM NORMALLY INCLUDES A SUNTECH TANGO M2 DEVICE .PATIENT CAUSE OF DEATH AND HOW THE TANGO DEVICE WAS USED HAS NOT BEEN CONFIRMED.

    Patient problems: Insufficient Information

    MAUDE report 12294003 ↗

Other System, Measurement, Blood-Pressure, Non-Invasive devices

All System, Measurement, Blood-Pressure, Non-Invasive devices →

Sources and updates

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