BrachyStar™ 918201Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741075957), received between Nov 21, 2018 and Aug 25, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Incorrect Measurement; Material Deformation; Incorrect Measurement; Material Deformation

  ON 30-JUL-2025, A PATIENT WAS UNDERGOING A BRACHYTHERAPY PROCEDURE. BEFORE USE OF THE NEEDLE, IT WAS REPORTED THAT THE PINK PART OF THE BRACHY NEEDLE STYLET OR CANNULA HAD A SHAPE DEFECT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882008 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A BRACHYTHERAPY PROCEDURE. BEFORE USE OF THE NEEDLE, IT WAS REPORTED THAT THE PINK PART OF THE BRACHY NEEDLE STYLET OR CANNULA HAD A SHAPE DEFECT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881939 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A BRACHYTHERAPY PROCEDURE. BEFORE USE OF THE NEEDLE, IT WAS REPORTED THAT THE PINK PART OF THE BRACHY NEEDLE STYLET OR CANNULA HAD A SHAPE DEFECT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881933 ↗
• MalfunctionFeb 22, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO A BRACHYTHERAPY PROCEDURE, THE NEEDLE WAS ALLEGEDLY NOTED TO BE CURVED UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576928 ↗
• MalfunctionAug 25, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE NEEDLE WAS ALLEGEDLY FOUND TO BE BENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364903 ↗
• MalfunctionAug 25, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE NEEDLE WAS ALLEGEDLY FOUND TO BE BENT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364900 ↗
• MalfunctionAug 6, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE INNER NEEDLE AND THE CANNULA WERE ALLEGEDLY NARROW AND NOT SMOOTH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286580 ↗
• MalfunctionNov 21, 2018Difficult to Insert

  IT WAS REPORTED THAT THE USER FOUND IT DIFFICULT TO INSERT THE NEEDLE THUS, ANOTHER NEEDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8097127 ↗