BrachySource™ PS1251LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741078200), received between Sep 27, 2017 and Apr 3, 2020 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2020Component Missing

  IT WAS REPORTED THAT THE CUSTOMER CALLED TO ORDER SEEDS THAT THEY WANTED TO USE ON (B)(6)2020 . THE ORDER WAS A REQUEST FOR A TOTAL OF 132 SEEDS ( 120 SEEDS IN 1 VIAL AND 12 SEEDS IN A SEPARATE VIAL) .THE ORDER WAS RECEIVED ON(B)(6)2020 AND THE CUSTOMER REALIZED THAT THERE WAS A MISSING SEED (B)(6)2020 . THE CUSTOMER STATED THEY RECEIVED 120 SEEDS IN 1 VIAL AND 11 SEEDS IN A SEPARATE VIAL. THE BRACHY CUSTOMER SERVICE LOCATED THE ORIGINAL ORDER AND NOTIFIED THE CUSTOMER THAT THEY FILLED THE ORDER BASED ON THE DIRECTIVE PROVIDED.

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

  MAUDE report 9923597 ↗
• MalfunctionMay 4, 2018Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE FACILITY RECEIVED SEEDS WITH PRODUCT CODES 1251CSR AND 1251CSRA (SALES ORDER (B)(4)) THAT WERE INTENDED FOR A DIFFERENT FACILITY INSTEAD OF THE SEEDS THAT WERE ORDERED (PS1251LS - SALES ORDER (B)(4)). THE INITIAL INVESTIGATION INTO THE ISSUE INDICATES THAT THE FEDEX LABELS ON THE OUTER SHIPPING BOXES WERE SWITCHED. THE PATIENT WAS REPORTEDLY UNABLE TO UNDERGO THE SCHEDULED SURGERY AND AN ADDITIONAL SURGERY WAS SCHEDULED FOR A LATER DATE. THIS FACILITY WAS UNABLE TO COMPLETE THE SCHEDULED PROCEDURE FOR THEIR PATIENT; THEREFORE, AN ADDITIONAL SURGERY WAS SCHEDULED. HOWEVER, THE SEEDS ALLEGED AGAINST (PS1251LS) WERE USED ON A PATIENT AT ANOTHER FACILITY ((B)(6) HOSPITAL) PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT'S SURGERY WAS RESCHEDULED AND COMPLETED ON (B)(6) 2018.

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

  MAUDE report 7488238 ↗
• MalfunctionMar 27, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE COMPLAINANT OPENED THE VIAL TO EXTRACT THE SEEDS, THERE WAS A POWDERY BLACK SUBSTANCE THAT SPILLED FROM THE CONTAINER . THE REPORTED EVENT OCCURRED BEFORE PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7373873 ↗
• MalfunctionSep 27, 2017Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT THE FACILITY RECEIVED THE INCORRECT NUMBER OF SEEDS WITH THE INCORRECT ACTIVITY ((B)(4)). PER THE COMPLAINANT, "WE HAD ORDERED A TOTAL OF 82 SEEDS FOR PLAN 31, CONSISTING OF 76 SEEDS IN NEEDLES PLUS 8 LOOSE SEEDS FOR QA PURPOSES. THE VIAL OF LOOSE SEEDS WE RECEIVED CONTAINED 9 LOOSE SEEDS. ONE OF THESE SEEDS WAS NOT THE CORRECT ACTIVITY FOR THIS PATIENT...IF THERE IS ANY POSSIBILITY THAT THE NEEDLE ACTIVITIES COULD HAVE BEEN MIXED UP WE WILL NEED TO CANCEL THE PATIENT URGENTLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896962 ↗

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