Intracept FG 0043Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00852454006004), received between Feb 12, 2025 and Feb 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PROCEDURE FACED ISSUES WITH HIGH IMPEDANCE ON THE ORIGINAL PROBE AT THE L5 VERTEBRAL BODY ON BOTH SIDES. THE PROBE WAS SWITCHED OUT WITH A NEW ONE. DESPITE CLEARING THE TRACT AND USING A NEW PROBE THE HIGH IMPEDANCES OCCURRED AGAIN BUT ON THE RIGHT SIDE OF L5. THE CURVED CANNULA ALSO BECAME STUCK IN L5, REQUIRING FORCE AND TWISTING IN ORDER TO REMOVE. THE PATIENT'S BONE WAS NOTABLY HARD. THE PEEK MATERIAL OF THE CURVED CANNULA SHEARED OFF IN THE LEFT SIDE OF L5. A NEW CURVED CANNULA WAS USED TO ACCESS THE RIGHT SIDE L5, IT ALSO SEEMED STUCK AND EVENTUALLY BROKE AT THE PROXIMAL END BUT WAS FULLY RETRIEVED WITH HEMOSTATS. THE PATIENT'S BONE ON THIS SIDE WAS NOT AS HARD BUT DENSE. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. DUE TO THESE COMPLICATIONS, L5 WAS NOT ABLATED, AND L4 WAS NOT ATTEMPTED. THE PROCEDURE WAS ABORTED. THE PATIENT HAD NO REPORTED COMPLAINTS BEFORE DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367971 ↗
• MalfunctionFeb 12, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING AN INTRACEPT PROCEDURE, THE PROCEDURE FACED ISSUES WITH HIGH IMPEDANCE ON THE ORIGINAL PROBE AT THE L5 VERTEBRAL BODY ON BOTH SIDES. THE PROBE WAS SWITCHED OUT WITH A NEW ONE. DESPITE CLEARING THE TRACT AND USING A NEW PROBE THE HIGH IMPEDANCES OCCURRED AGAIN BUT ON THE RIGHT SIDE OF L5. THE CURVED CANNULA ALSO BECAME STUCK IN L5, REQUIRING FORCE AND TWISTING IN ORDER TO REMOVE. THE PATIENT'S BONE WAS NOTABLY HARD. THE PEEK MATERIAL OF THE CURVED CANNULA SHEARED OFF IN THE LEFT SIDE OF L5. A NEW CURVED CANNULA WAS USED TO ACCESS THE RIGHT SIDE L5, IT ALSO SEEMED STUCK AND EVENTUALLY BROKE AT THE PROXIMAL END BUT WAS FULLY RETRIEVED WITH HEMOSTATS. THE PATIENT'S BONE ON THIS SIDE WAS NOT AS HARD BUT DENSE. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. DUE TO THESE COMPLICATIONS, L5 WAS NOT ABLATED, AND L4 WAS NOT ATTEMPTED. THE PROCEDURE WAS ABORTED. THE PATIENT HAD NO REPORTED COMPLAINTS BEFORE DISCHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367938 ↗