General instrumentation IG025RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663037709), received between Feb 13, 2026 and Feb 13, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY.THIS IS REPORT FIVE OF SIX FOR THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 24334931 ↗