ALLY Uterine Positioning System® AU-UPSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937015836), received between Sep 9, 2020 and Jul 1, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

1 other recall cover devices cleared under the same FDA submission (K141523); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJul 1, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6), 2025. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A RECTAL INJURY AND A LEFT URETERAL INJURY. SHE WAS THEN CONVERTED TO AN EXPLORATORY LAPAROTOMY AND AN OPEN HYSTERECTOMY/OOPHORECTOMY WERE COMPLETED. PATIENT UNDERWENT A DIVERTING LOOP ILEOSTOMY, RIGID PROCTOSCOPE WITH LEFT URETERAL. PATIENT WAS ADMITTED TO THE HOSPITAL. CUSTOMER REPORTED THAT THE UNIT'S ARM CABLE WIRE WAS FRAYING AND WAS SUBSEQUENTLY REPLACED AFTER THE INCIDENT. 1216677-2025-00035 AU-UPS ALLY 2025-06-0000238.

  Patient problems: Bowel Perforation; Uterine Perforation

  MAUDE report 22371535 ↗
• MalfunctionSep 9, 2020Material Split, Cut or Torn

  REPORT SUBMITTED BY CSI REP- INCIDENT REPORT: STERILE DRAPE RIPPED DURING HYSTERECTOMY CASE AND WHEN IT WAS REMOVED, THE ALLY ARM WAS COVERED IN PATIENT BLOOD AND FLUID. CLEANED OFF AS MUCH AS POSSIBLE WITH ALCOHOL, BUT NEED TO BE STERILIZED BEFORE USE ON ANOTHER PATIENT". (B)(4). 1216677-2020-00203 ALLY UPS AU-UPS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10508519 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141523. One submission often covers many models, so check the product and lot details in each record.

• Z-1727-2015 · May 18, 2015 · Terminated
  Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS