BrachySource™ PS1251CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741078224), received between Jul 26, 2019 and Jul 13, 2021 — classified as 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K093663); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CARTRIDGE ALLEGEDLY JAMMED AND THE SEEDS WERE NOT ABLE TO BE RELEASED FROM THE CARTRIDGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12157286 ↗
• MalfunctionJan 6, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE PRODUCT LABELING WAS INCORRECT. REPORTEDLY, THE PATIENT RECEIVED THE PROPER DOSAGE OF RADIATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11127300 ↗
• MalfunctionJul 26, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem; Component Missing

  IT WAS REPORTED THAT THE STANDARD ASSAY CERTIFICATES WERE MISSING FROM THE PACKAGE.

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

  MAUDE report 8831101 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093663. One submission often covers many models, so check the product and lot details in each record.

• Z-1702-2018 · Apr 10, 2018 · Terminated
  BARD BrachySource Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference F