INTRABEAM® Needle Applicator 304534-3001-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049539101372), received between Aug 2, 2016 and Aug 2, 2016 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K110590); 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 18, 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.

• InjuryAug 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOR AN INTRAOPERATIVE RADIOTHERAPY (IORT) DURING KYPHOPLASTY SURGERY, THE INTRABEAM SYSTEM IS USED TOGETHER WITH AN INTRABEAM NEEDLE APPLICATOR IN ORDER TO TREAT INTERSTITIAL IRRADIATION OF TUMORS. THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE INTRABEAM FEMALE GUIDING SLEEVE, WHICH IS A COMPONENT OF THE INTRABEAM NEEDLE APPLICATOR SET, WAS PLACED INTO THE PEDICLE AND VERTEBRA WITH TOO MUCH PRESSURE CAUSING THE SLEEVE TO MOVE COMPLETELY INTO THE PEDICLE AND VERTEBRA. AS A CONSEQUENCE, IORT COULD NOT BE DELIVERED DURING THE PLANNED KYPHOPLASTY SURGERY WITH VERTEBROPLASTY. THE HCP COULD NOT REMOVE THE PENETRATED INTRABEAM FEMALE GUIDING SLEEVE AND HE DECIDED TO CEMENT THE GUIDING SLEEVE IN THE PEDICLE LIKE A PEDICLE SCREW, WHICH WAS DONE DURING THE RESPECTIVE STANDARD CEMENTATION PROCEDURE. THE HCP CONFIRMED THAT THE PENETRATION OF THE GUIDING SLEEVE AND ITS CEMENTATION DID NOT CAUSE ANY HARM TO THE PATIENT. THE REQUIRED RADIATION DOSE WAS DELIVERED AFTERWARDS VIA EXTERNAL BEAM RADIOTHERAPY.

  Patient problems: No Code Available

  MAUDE report 5842177 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110590. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2018 · Aug 30, 2017 · Terminated
  Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy