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ACUMED 10100015Recalls & reported problems

Acumed LLC · ARC Wrist Tower Upper Arc · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10806378010095), received between Feb 16, 2026 and Feb 16, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Use of Device Problem2

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.

  • InjuryFeb 16, 2026Use of Device Problem

    IT WAS REPORTED THAT WHILE CROSS THREADING ON 2 SEPARATE ARC WRIST TOWERS, THE TOWER ARM AND TENSION KNOB GOT STUCK AND WOULD NOT MOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER ARC WRIST TOWER. A REPORTED DELAY OF 20 MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24351651 ↗
  • InjuryFeb 16, 2026Use of Device Problem

    IT WAS REPORTED THAT WHILE CROSS THREADING ON 2 SEPARATE ARC WRIST TOWERS, THE TOWER ARM AND TENSION KNOB GOT STUCK AND WOULD NOT MOVE. THE PROCEDURE WAS COMPLETED USING ANOTHER ARC WRIST TOWER. A REPORTED DELAY OF 20 MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24351647 ↗

Other APPARATUS, TRACTION, NON-POWERED devices

All APPARATUS, TRACTION, NON-POWERED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.