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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00615521020101), received between Sep 29, 2025 and Dec 2, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEVELOPED COMPARTMENT SYNDROME WHILE IN ALLEN YELLOFIN STIRRUPS WITH LIFT-ASSIST DURING AN ENDOMETRIAL SURGICAL PROCEDURE VIA LAPAROSCOPY. ON THE DAY OF THE EVENT, ANESTHESIA AND LIMB POSITIONING BEGAN AT 08:00 AND THE PROCEDURE STARTED AT 09:00. AT 15:50 THE PROCEDURE WAS COMPLETED AND ANESTHESIA ¿WORE OFF¿ AT 16:05. IMMEDIATELY UPON WAKING WHILE STILL IN THE OPERATING ROOM THE PATIENT COMPLAINED OF LOWER LIMB PAIN. THE PATIENT WAS ¿TRANSFERRED TO THE ROBOTIC PROCESS AUTOMATION.¿ A VASCULAR SURGEON EVALUATED THE PATIENT AND NOTED BILATERAL COMPARTMENT SYNDROME AND INDICATED AN EMERGENCY FASCIOTOMY PROCEDURE WAS REQUIRED IN BOTH LOWER LIMBS. THE FASCIOTOMY PROCEDURE BEGAN AT 19:15 AND WAS COMPLETED AT 20:00. POST OPERATIVELY THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING AND ANALGESIA FOR PAIN MANAGEMENT VIA PCA PUMP. FOUR DAYS LATER, A FOLLOW UP PROCEDURE WAS REQUIRED FOR ¿CLOSURE OF THE RIGHT POSTERIOR COMPARTMENT FASCIOTOMY AND LEFT ANTERIOR COMPARTMENT FASCIOTOMY, PLUS THE IMPLANTATION OF A DECORATIVE INSERT AND A DISPOSABLE LEFT POSTERIOR FASCIOTOMY.¿ THE NEXT DAY THE PATIENT WAS DISCHARGED FROM ICU. CURRENTLY THE PATIENT

  Patient problems: Compartment syndrome

  MAUDE report 23696125 ↗
• MalfunctionSep 29, 2025Unintended Movement; Unintended Movement

  BAXTER RECEIVED A REPORT STATING THAT DURING ANESTHESIA RECOVERY OF A PATIENT UNDERGOING CERVICAL CONIZATION, THE FOOT SUPPORT AND THE LOCKING OF THE ADJUSTING ARM OF THE YELLOFIN STIRRUPS WERE LOOSENED, AND THE PATIENT'S LEGS FELL DOWN WITH THE FOOT SUPPORT. AT THAT TIME, IT WAS ASSESSED THAT NO ADVERSE HARM OCCURRED. . THE PATIENT WAS EVALUATED AGAIN HALF AN HOUR AND 12 HOURS AFTER RETURNING TO THE WARD, AND NO ABNORMALITIES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23168863 ↗