FullFire® Select Diffusing Tip Laser Probe 20624-00 (REF FFS002-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589020465), received between Sep 22, 2017 and Sep 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K143457); they may or may not involve this specific model.

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.

• MalfunctionSep 22, 2017Temperature Problem; Temperature Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD NO ADVERSE EVENTS. THE PATIENT IS NOW DECEASED BUT THE DEATH IS NOT ATTRIBUTED TO NEUROBLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6887370 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143457. One submission often covers many models, so check the product and lot details in each record.

• Z-1614-2016 · Mar 25, 2016 · Terminated
  NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate S