QuickLink™, BrachySource™ 1251QCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741078354), received between Jan 12, 2018 and Feb 20, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PRIOR TO A BRACHYTHERAPY PROCEDURE, THE CARTRIDGE COUNTERS WERE ALLEGEDLY INACCURATE AS THERE WERE ALLEGEDLY ELEVEN SEEDS IN A CARTRIDGE WHICH WAS SUPPOSED TO HAVE ONLY TEN SEEDS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738391 ↗
• MalfunctionAug 1, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT DURING BRACHYTHERAPY PROCEDURE, THE CERTIFICATE SUPPLIED IN THE ENVELOPE ALLEGEDLY DID NOT BEAR THE SAME INFORMATION AS THE CERTIFICATES STUCK ON AND INSIDE THE BOX OF IODINE GRAINS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434753 ↗
• MalfunctionAug 1, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT DURING BRACHYTHERAPY PROCEDURE, THE CERTIFICATE SUPPLIED IN THE ENVELOPE ALLEGEDLY DID NOT BEAR THE SAME INFORMATION AS THE CERTIFICATES STUCK ON AND INSIDE THE BOX OF IODINE GRAINS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434752 ↗
• MalfunctionMar 16, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Non-Healthcare Professional; Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Non-Healthcare Professional

  IT WAS REPORTED THAT PRIOR TO A BRACHYTHERAPY PROCEDURE, THE DEVICE WAS DELIVERED TO GENERAL WAREHOUSE OF THE HOSPITAL INSTEAD OF IN THE RADIOPHYSICS SERVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492223 ↗
• MalfunctionJan 12, 2018Mechanical Jam

  IT WAS REPORTED THAT THE NEW CARTRIDGE AND PRESSING THE NORMAL SEED BUTTON ON THE LOADER FELT FINE BUT NOTHING CAME OUT, AS CONFIRMED BY OPENING THE SECOND BUTTON (RELAY END) AND INSERTING A NEEDLE. THE CARRIER WAS COMPLETELY JAMMED. AFTER SEVERAL MORE TRIES, THE BUTTON DID RELEASE AND EVERYTHING APPEARED TO BE FREED UP AGAIN BUT THERE WAS STILL NO SIGN OF A SEED EXPELLED. TRIED TO EXPEL ANOTHER SEED AND EVERYTHING COMPLETELY JAMMED AS ABOVE BUT THIS TIME NOTHING COULD BE RELEASED AT ALL, INCLUDING THE CARTRIDGE WHICH AT THIS POINT SHOWED THAT 3-5 SEEDS HAD BEEN EJECTED SOMEWHERE. WE CHANGED TO THE OTHER LOADER AND CONTINUED TO THE END WITH ANOTHER CARTRIDGE, NUMBER 4, WHICH WAS FINE. AT THE END OF THE PROCEDURE EVERYTHING WAS STILL JAMMED BUT WE MANAGED TO REMOVE THE CARTRIDGE ASSEMBLY AND THERE WERE 4 SEEDS WITHIN THE LOADER, 1 ON THE BASEPLATE, 2 ON TOP OF EACH OTHER WITHIN THE ¿BLADE¿ MECHANISM WHICH WERE JAMMING EVERYTHING UP. THEY WERE STUCK BUT COULD BE REMOVED WITH TWEEZERS AS THEY WERE REALLY ONLY JAMMING THEMSELVES IN. THE FINAL 1 SEED, WITH ALL OF THE MOVING OF THE VARIOUS MECHANISMS AND STYLET HAD MOVED INTO THE NORMAL CHANNEL.

  Patient problems: No Information

  MAUDE report 7185883 ↗

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