QuickLink™, BrachySource™ 1251QCLRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741078378), received between Nov 9, 2017 and Jan 2, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2018Sticking; Mechanical Jam

  IT WAS REPORTED THAT THE CARTRIDGE JAMMED. THE SEEDS WERE STUCK IN THE CARTRIDGE AND THE PATIENT DID NOT RECEIVE ALL THE SEEDS AS PLANNED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7157958 ↗
• MalfunctionDec 29, 2017Failure to Align; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SEEDS WOULD NOT COME OUT OF OUR CALIBRATION CARTRIDGE NO MATTER HOW MANY TIMES IT WAS RELOADED, RE-ALIGNED, PUSHED DOWN ON IT ETC ETC NOTHING HAPPENED. THERE APPEARED TO BE SOME SORT OF MISALIGNMENT AS THE ¿EXPEL¿ BUTTON WAS JUST SOLID AND WOULDN¿T DEPRESS PROPERLY. ALSO ON A SECOND CARTRIDGE A SEED FELL THROUGH THE LOADER AND ONTO THE BASEPLATE BUT WE HAVE HAD THAT ON ONE OTHER PREVIOUS OCCASION. IT JUST APPEARED TO FALL OUT IE. "I DIDN¿T TRY AND LOAD IT INTO A SOURCE TRAIN AND IT JUST DIDN¿T APPEAR IN THE SOURCE TRAIN WINDOW REQUIRING ME TO HAVE A SECOND ATTEMPT OF DEPRESSING THE ¿EXPEL¿ BUTTON." ALL SOURCE TRAINS MADE UP OK FROM THAT CARTRIDGE BUT IT WAS JUST AT THE END OF THE CARTRIDGE THAT A SEED WAS ¿MISSING¿ IE. "I HAD 1 LESS SEED IN THE CARTRIDGE THAN I WAS EXPECTING NAMELY THE ONE THAT HAD FALLEN THROUGH." THE PATIENT DID NOT RECEIVED ALL SEEDS.

  Patient problems: Underdose

  MAUDE report 7155506 ↗
• MalfunctionDec 29, 2017Failure to Align; Computer Operating System Problem; Mechanics Altered

  IT WAS REPORTED THAT THE SEEDS WOULD NOT COME OUT OF OUR CALIBRATION CARTRIDGE NO MATTER HOW MANY TIMES IT WAS RELOADED, RE-ALIGNED, PUSHED DOWN ON IT ETC, ETC NOTHING HAPPENED. THERE APPEARED TO BE SOME SORT OF MISALIGNMENT AS THE ¿EXPEL¿ BUTTON WAS JUST SOLID AND WOULDN¿T DEPRESS PROPERLY. ALSO, ON A SECOND CARTRIDGE A SEED FELL THROUGH THE LOADER AND ONTO THE BASEPLATE, BUT WE HAVE HAD THAT ON ONE OTHER PREVIOUS OCCASION. IT JUST APPEARED TO FALL OUT IE. "I DIDN¿T TRY AND LOAD IT INTO A SOURCE TRAIN AND IT JUST DIDN¿T APPEAR IN THE SOURCE TRAIN WINDOW REQUIRING ME TO HAVE A SECOND ATTEMPT OF DEPRESSING THE ¿EXPEL¿ BUTTON." ALL SOURCE TRAINS MADE UP OK FROM THAT CARTRIDGE BUT IT WAS JUST AT THE END OF THE CARTRIDGE THAT A SEED WAS ¿MISSING¿ IE. "I HAD 1 LESS SEED IN THE CARTRIDGE THAN I WAS EXPECTING NAMELY THE ONE THAT HAD FALLEN THROUGH." THE PATIENT DID NOT RECEIVED ALL SEEDS.

  Patient problems: Radiation Underdose

  MAUDE report 7155458 ↗
• InjuryNov 9, 2017Misassembled

  IT WAS REPORTED THAT THE SEED ACTIVITY ON THE LOCAL ASSAY WAS NOT IN THE NORMAL AGREEMENT WITH EACH OTHER. (THE FACILITY VERIFIED THIS FROM THEIR SEED ACTIVITY MEASUREMENTS AND PAPERWORK) DUE TO THE CONCERN OVER THE CORRECT ACTIVITY, THE PHYSICIAN CHOSE TO CANCEL THE (B)(6) 2017 IMPLANT AND RESCHEDULE WITH A NEW SET OF SEEDS FOR IMPLANT ON (B)(6) 2017. THIS IS THE EXTENT OF THE INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 7015186 ↗

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