ALLEN 108001Recalls & reported problems
Hill-Rom, Inc. · Boot Assembly, Traction Device,OT 1000 · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00615521000851), received between Feb 6, 2024 and Feb 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Feb 14, 2024Open, Classified
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
Z-1289-2024 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
BAXTER RECEIVED A REPORT FROM A DISTRIBUTOR NOTING IT WAS FOUND 2 NON-SERIALIZED TRACTION BOOTS FROM SAME LOT (23-268), WHERE THE BOOT BASE HAS BEEN INSTALLED IS FACING THE WRONG DIRECTION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660886 ↗MalfunctionFeb 7, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
BAXTER RECEIVED A REPORT FROM A CUSTOMER NOTING TRACTION BOOT WHERE THE BOOT BASE HAS BEEN INSTALLED IS FACING THE WRONG DIRECTION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18660707 ↗MalfunctionFeb 6, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
BAXTER RECEIVED A REPORT FROM A CUSTOMER NOTING TRACTION BOOT WHERE THE BOOT BASE HAS BEEN INSTALLED IS FACING THE WRONG DIRECTION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18652130 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.