ALLEN 102001 (REF O-YFAX)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00615521030629), received between Mar 31, 2023 and Sep 9, 2026 — classified as 1 injury, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Device Fell

  Baxter received a report that YELLOFINS APEX STRUP PAIR had the stirrup dropped unexpectedly . There was no patient/user injury, medical intervention, symptom, or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681355 ↗
• InjuryMar 31, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT WITH USE OF THE YELLOWFIN ELITE STIRRUPS THE PATIENT EXPERIENCED PERONEAL NERVE DAMAGE POSTOPERATIVELY. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER STATES THE PATIENT WAS IN THE STIRRUPS FOR APPROXIMATELY SIX HOURS OR MORE. THE SURGEON WAS UNABLE ABLE TO CONFIRM IF POSITIONING OR THE STIRRUP WAS THE CAUSE OF THE NERVE DAMAGE BUT STATES IT COULD BE A POSSIBILITY. THE CUSTOMER WAS UNABLE TO VERIFY THE DEVICE REFERENCE OR LOT NUMBERS; HOWEVER, PROVIDED NUMBERS (UNDETERMINED IF SERIAL NUMBERS) (B)(6) FOR THE RIGHT STIRRUP AND (B)(6) FOR THE LEFT. THESE ARE NOT DEVICE SERIAL NUMBERS OF HILLROM¿S PRODUCTS. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 16656095 ↗