Orbiter™ PV M0043201000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729877967), received between Dec 22, 2021 and Mar 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 16 FEBRUARY 2022. IT WAS REPORTED THAT A ORBITER PV WAS SELECTED TO BE USED IN PROCEDURE. DURING THE INTRODUCTION OF THE CATHETER INTO THE SHEATHS HEMOSTATIC VALVE THE CATHETER TIP WAS DAMAGED WHILE CROSSING. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE TIP WAS PARTIALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792491 ↗
• MalfunctionDec 22, 2021Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN ORBITER PV ELECTRODE CATHETER, UPON INTRODUCTION AND VISUAL INSPECTION BY THE PHYSICIAN EVERYTHING WAS OK. DURING THE PROCEDURE VERY HIGH SIGNAL NOISES OCCURRED. THE PHYSICIAN REMOVED THE CATHETER AND SAW THE WIRE OUT OF THE ELECTRODE. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH ANOTHER ORBITER PV. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13069209 ↗