OptaBlate 9700015200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327524512), received between Jun 5, 2023 and Mar 26, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• InjuryMar 26, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A BONE TUMOR ABLATION USING AN OPTABLATE DEVICE. AFTER THE PROCEDURE, THE PATIENT WAS UNABLE TO MOVE ONE OF THEIR LEGS. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION.

  Patient problems: Paralysis

  MAUDE report 21699898 ↗
• MalfunctionJun 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE PROBE BROKE OFF DURING THE PROCEDURE. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY MEDICAL INTERVENTION, SURGICAL DELAYS, OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621211 ↗
• MalfunctionJun 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE WHILE POSITIONING THE PROBE UNDER FLUOROSCOPY THE TIP OF THE PROBE WAS NOTED TO BE BROKEN OFF BUT NOTHING WAS LEFT BEHIND IN THE PATIENT. A NEW PROBE WAS USED TO COMPLETE THE PROCEDURE WITHOUT MEDICAL INTERVENTION, DELAY, OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059994 ↗