BrachySource™ 1251CSRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741078262), received between May 3, 2018 and Mar 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2019Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE SEEDS WERE SHIPPED TO SURGERY FOR UROLOGY IN (B)(6) INSTEAD OF (B)(6) MEDICAL CENTER IN (B)(6). THE SEEDS HAD TO BE DRIVEN TO (B)(6) MEDICAL CENTER FROM (B)(6) FOR THE SCHEDULED IMPLANT. THERE WAS A 2-3 HOUR SURGICAL DELAY DUE TO THE DELIVERY ERROR. HOWEVER, THE PATIENT RECEIVED THEIR FULL PRESCRIBED DOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8425323 ↗
• MalfunctionMay 3, 2018Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional; Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE FACILITY RECEIVED SEEDS WITH PRODUCT CODE (B)(4) (SALES ORDER (B)(4)) THAT WERE INTENDED FOR A DIFFERENT FACILITY, INSTEAD OF THE SEEDS THAT WERE ORDERED (1251CSR AND 1251CSRA - SALES ORDER (B)(4)). THE INITIAL INVESTIGATION INTO THE ISSUE INDICATES THAT THE FEDEX LABELS ON THE OUTER SHIPPING BOXES WERE SWITCHED. THE SEEDS THAT THE FACILITY RECEIVED ((B)(4)) WERE REPORTEDLY USED ON THE PATIENT AND THE PATIENT RECEIVED THE CORRECT DOSAGE WITHOUT IMPACT.

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

  MAUDE report 7485823 ↗

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