VAPR ARCTIC 225030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705022519), received between Jan 29, 2019 and Jan 30, 2019 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A HIP SCOPE THE TIP OF ELECTRODE BROKE AND BENDING MECHANISM WOULDN¿T WORK ANYMORE. ANOTHER ELECTRODE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288557 ↗
• MalfunctionJan 29, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A HIP PROCEDURE THE MECHANISM THAT ALLOWS THE ARTICULATING TIP TO MOVE ON TWO OF THE VAPR ARCTIC HIP CHISEL TIP ELECTRODES IS BROKEN. NOTHING BROKE OFF IN THE PATIENT AND THAT THE ELECTRODES ARE FROM THE SAME LOT NUMBER. THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD DEVICE FROM THE SAME LOT NUMBER WITH NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286363 ↗