ACUFEX 7207047Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010252906), received between Oct 25, 2018 and Nov 22, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A CUFF REPAIR SURGERY, THE NEW ACUFEX-PRO SCISSOR BROKE AS IT WAS USED TO TAKE A BITE OF SOFT TISSUE. ALL THE DEVICE FRAGMENTS WERE REMOVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363218 ↗
• MalfunctionNov 19, 2018Break

  IT WAS REPORTED THAT THE UNIT WAS BROKEN. THE DEVICE BROKE INSIDE THE PATIENT. PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8086174 ↗
• MalfunctionOct 25, 2018Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. ALL PIECES WERE REMOVED AND NO PATIENT INJURY WERE REPORTED. SURGERY WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005195 ↗