Budde® A1040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780253419), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K830332); 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.

• MalfunctionMar 30, 2026Unstable

  A FACILITY REPORTED THAT DURING A BRAIN TUMOR RESECTION, THE HALO FLEX ARM OF THE BUDDE HALO RETRACTOR SYSTEM (A1040) WAS NOT TIGHTENING. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS SURGICAL DELAY OF AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715406 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830332. One submission often covers many models, so check the product and lot details in each record.

• Z-0781-03 · Feb 26, 2003 · Terminated
  Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defecti