BrachySource™ PS1251CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741078217), received between Jan 28, 2022 and Jan 28, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO A BRACHYTHERAPY PROCEDURE, THE INFORMATION PROVIDED IN THE DEVICE TAG WAS UNCLEAR AS IT DENOTED AN EXPIRY DATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13382597 ↗

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