BIOPSYBELL EASYNJECTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033860036584), received between May 1, 2026 and May 1, 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. How this data works · Data updated Oct 13, 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.

• InjuryMay 1, 2026Device Dislodged or Dislocated

  THE PATIENT DID HAVE CANAL COMPRESSION AND HAD TO BE MONITORED. NO OTHER PERSON IN THE ROOM WAS AFFECTED. PATIENT DID NOT HAVE MORTALITY ONLY COMPLICATION DUE TO CEMENT BEING INJECTED INTO SPINAL COLUMN. THE CEMENT WAS INJECTED AFTER WAITING FIVE MINUTES POST MIXING WITH INJECTION BETWEEN EIGHT AND 10 MINUTES, CEMENT LEAKED ON LEVEL 3 AFTER WAITING OVER 5-8 MINUTES POST MIXING. THE TROCARS WERE BEYOND THE POSTERIOR THIRD AND IN BIPEDICULAR SETUP. SURGEON BELIEVES THE KVTGUN HAD TO MUCH PRESSURE.

  Patient problems: Stenosis

  MAUDE report 25061765 ↗