Arthrex AR-1650-01Recalls & reported problems
Allen Medical Systems, Inc. · Shoulder Suspension Tower · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00615521004521), received between Aug 15, 2025 and Dec 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Collapse” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Collapse1
- Detachment of Device or Device Component1
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.
MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
BAXTER RECEIVED A REPORT STATING THAT DURING A SHOULDER PROCEDURE, A SHOULDER SUSPENSION TOWER HAD ITS BLUE CORD TIED TO THE UNIT AND SNAPPED OFF DURING THE SURGERY. THE PATIENT WAS UNINJURED, AND THE PROCEDURE WAS FINISHED WITHOUT INCIDENT. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23823818 ↗MalfunctionAug 15, 2025Collapse; Collapse
BAXTER RECEIVED A REPORT STATING THAT SHOULDER SUSPENSION TOWER FELL TO THE FLOOR AND KNOCKED A PIECE OF AXIS, MAKING IT IMPOSSIBLE TO GLIDE, SUSPEND OR LOCK. THE DEVICE WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22816679 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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