ZUMI ZSI1151Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937013221), received between Jan 8, 2026 and Feb 3, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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.

• MalfunctionFeb 3, 2026Material Separation

  IT WAS REPORTED THAT THEUTERINE MANIPULATOR WAS BEING USED DURING A LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY (LBSO), IT WAS UNKNOWN AT THE TIME THAT THE TIP OF THE DEVICE HAD BROKEN OFF INTO THE PATIENT. THE PATIENT CALLED THE OB CLINIC INFORMING THEM SOMETHING HAD BEEN EXPELLED FROM HER VAGINA, OF WHICH APPEARS TO BE THE TIP (2INCH) OF THE ZUMI, WHERE THE CUFF IS INFLATED UPON INSERTION INTO THE CERVIX. ATTEMPTS HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 1216677-2026-00006 ZSI1151 ZUMI (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246228 ↗
• MalfunctionJan 8, 2026

  UTERINE MANIPULATOR WAS BEING USED DURING AN LBSO [LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY], IT WAS UNKNOWN AT THE TIME THAT THE TIP OF THE DEVICE HAD BROKEN OFF INTO THE PATIENT. THE PATIENT CALLED THE OB CLINIC ON [REDACTED] INFORMING THEM SOMETHING HAD BEEN EXPELLED FROM HER VAGINA, OF WHICH APPEARS TO BE THE TIP (2INCH) OF THE ZUMI, WHERE THE CUFF IS INFLATED UPON INSERTION INTO THE CERVIX.

  Patient problems: Foreign Body In Patient

  MAUDE report 24002645 ↗