NA 2245-10-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295107606), received between Mar 25, 2019 and May 8, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT A BLUNT POINT GELPI RETRACTOR HAD ONE OF ITS PRONGS BREAK OFF INTRAOPERATIVELY DURING A SURGICAL PROCEDURE. THE EVENT INVOLVED A SINGLE DEVICE, AND THERE WAS NO REPORTED PATIENT OR USER HARM, NOR WAS THERE A SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122795 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT THE ATTUNE FEMORAL INTRODUCER EXPERIENCED A BROKEN HANDLE WITH THE KNOB BREAKING OFF, WHILE THE BLUNT POINT GELPI RETRACTOR HAD A BROKEN TOOTH. THE EVENT DESCRIPTION INDICATES BOTH DEVICES BROKE INTO TWO OR MORE PIECES, BUT THERE IS INSUFFICIENT INFORMATION REGARDING THE EXACT CIRCUMSTANCES OF THE BREAKAGE OR ANY ASSOCIATED PATIENT IMPACT. THERE IS NO INDICATION THAT THE MALFUNCTIONS RESULTED IN ANY IMPACT TO AN EXPECTED SURGICAL OUTCOME OR CAUSED ANY PATIENT CONSEQUENCE OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24885951 ↗
• MalfunctionFeb 5, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT BLUNT GELPI BROKE AND WONT STAY OPEN AND NEEDS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272046 ↗
• MalfunctionNov 24, 2020Break; Mechanical Jam; Break; Mechanical Jam

  SPRING IN THE GELPI SELF RETRACTOR IS SHOT. NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897804 ↗
• MalfunctionMay 8, 2019Break; Break

  I WAS REPORTED THAT AFTER DECONTAMINATION IT WAS NOTICED THAT THE BLUNT POINT GELPI RETRACTOR WAS NO LONGER SELF RETAINING. AFTER THE REVIEW OF THE INSTRUMENT, IT WAS DETERMINED TO BE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8592604 ↗
• MalfunctionMar 25, 2019Break; Break

  DOUBLE GELPIES BROKE PRIOR TO CASE. NO ADVERSE IMPACT ON PATIENT. NO DELAY TO PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450386 ↗