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QuickLink™ 70310QCA1Recalls & reported problems

Bard Brachytherapy, Inc. · QuickLink™ Delivery System QuickLink™ Loader · Class 1

Adverse event reports
16
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741079238), received between Aug 24, 2017 and Oct 5, 2021 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 reports).

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

Device problems

  • Physical Resistance/Sticking5
  • Break4
  • Positioning Problem3
  • Solder Joint Fracture2
  • Therapeutic or Diagnostic Output Failure2
  • Bent1
  • Connection Problem1
  • Device Dislodged or Dislocated1

Patient problems

  • No Known Impact Or Consequence To Patient10
  • No Clinical Signs, Symptoms or Conditions5
  • No Consequences Or Impact To Patient4
  • No Patient Involvement2

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 5, 2021Break; Break

    IT WAS REPORTED THAT THERE WAS A RATTLING NOISE IN THE BASS OF THE QUICKLINK DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12577190 ↗
  • MalfunctionMay 5, 2021Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE ALLEGEDLY HAD MATERIAL FRAGMENTATION ISSUE. THERE WAS REPORTED NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11776552 ↗
  • MalfunctionMar 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING A BRACHYTHERAPY PROCEDURE, GRAINS ALLEGEDLY FAILED TO LINE UP CORRECTLY WHEN PERCUSSING. IT WAS FURTHER REPORTED THAT THEY WERE ALLEGEDLY STUCK. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11580794 ↗
  • MalfunctionFeb 25, 2021Malposition of Device; Difficult to Advance; Physical Resistance/Sticking; Malposition of Device; Difficult to Advance; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SEEDS WERE ALLEGEDLY UNABLE TO BE PLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11378159 ↗
  • MalfunctionFeb 17, 2021Device Dislodged or Dislocated

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SILVER NOZZLE TIP ALLEGEDLY MISALIGNED WITH SPACE AND GROOVE CAUSING JAMS WHEN ATTEMPTING TO LOAD NEEDLES. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11336498 ↗
  • MalfunctionJun 17, 2020Physical Resistance/Sticking; Therapeutic or Diagnostic Output Failure; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE QUICK LINK LOADER TRANSPORT SEEDS AND SPACERS DID NOT WORK PROPERLY.

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

    MAUDE report 10165009 ↗
  • MalfunctionJun 17, 2020Fitting Problem; Fitting Problem; Connection Problem

    IT WAS REPORTED THAT THE STYLUS DOES NOT CONNECTED TO THE QUICK LINK SCREW THREAD.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10165007 ↗
  • MalfunctionFeb 12, 2020Positioning Problem; Therapeutic or Diagnostic Output Failure; Positioning Problem

    IT WAS REPORTED THAT IT WAS HARD TO LOAD THE SEEDS IN THE QUICKLINK LOADER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9700815 ↗
  • MalfunctionNov 27, 2019Physical Resistance/Sticking

    IT WAS REPORTED THAT THE SECOND BUTTON ON THE LEFT OF THE QUICKLINK LOADER WAS STAYING DOWNWARD AND WOULD NOT AUTOMATICALLY COME UP. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 07NOV2019. THE ISSUE WAS FOUND DURING PROCEDURE AND DID CAUSE SOME DELAY, AS THEY HAD TO FIND ANOTHER DEVICE TO COMPLETE THE PROCEDURE.

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

    MAUDE report 9386805 ↗
  • MalfunctionOct 2, 2019Break; Solder Joint Fracture; Solder Joint Fracture

    IT WAS REPORTED THAT THE QUICKLINK LOADER HAD BROKEN LEADED GLASS. IT WAS ALSO NOTED THAT THE MOVEMENT OF THE CARRIAGE WAS NOT FLUID. PER FOLLOW UP, IT WAS NOTED THAT THE DEVICE WAS USED ON A PATIENT DURING THE EVENT, BUT THERE WERE NO CLINICAL CONSEQUENCES.

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

    MAUDE report 9146143 ↗
  • MalfunctionOct 1, 2019Break; Solder Joint Fracture; Physical Resistance/Sticking; Solder Joint Fracture; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE QUICKLINK LOADER HAD BROKEN LEADED GLASS. THE MOVEMENT OF THE CARRIAGE WAS NOT FLUID.

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

    MAUDE report 9140838 ↗
  • MalfunctionApr 22, 2019Break

    IT WAS REPORTED THAT BASE AND COMPRESSION FRAME WAS BROKEN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8537429 ↗
  • MalfunctionMar 13, 2018Device Slipped; Failure to Advance

    IT WAS REPORTED THAT DURING A 3/4 CURIETHERAPIE PROCEDURE THERE WAS A PROBLEM WITH THE QUICKLINK APPLICATOR. IT HAD BLOCKED DUE TO THE FAILURE TO TIGHTEN A SCREW LOCATED UNDER THE RACK, PREVENTING THE ADVANCE OF THE NEEDLE. THE SCREW WAS LOOSENED DURING THE PROCEDURE SINCE THE TESTS AND THE PREPARATION OF 12 NEEDLES BEFORE HAD BEEN CARRIED OUT WITHOUT DIFFICULTY. THE CUSTOMER HAD TO TAKE A NEW APPLICATOR TO COMPLETE THE PROCEDURE. THERE WAS AN EXTENDED OPERATING TIME FOR THE PATIENT OF ABOUT 10 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7336173 ↗
  • MalfunctionNov 16, 2017Bent; Sticking; Positioning Problem; Bent

    IT WAS REPORTED THAT THE CHARGER SLID WITH DIFFICULTY. IT WAS LATER REPORTED, THE ISSUE WAS FOUND BEFORE PATIENT INVOLVEMENT AND THE SURGERY WAS CANCELLED.

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

    MAUDE report 7038601 ↗
  • MalfunctionNov 15, 2017Entrapment of Device; Device Inoperable

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING CORRECTLY AS THE GRAINS WERE STUCK INSIDE OF THE DEVICE. PER FOLLOW UP, THE ISSUE WAS FOUND DURING THE PROCEDURE AND THE PROCEDURE WAS STOPPED AND RESCHEDULED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7033070 ↗
  • MalfunctionAug 24, 2017Positioning Problem; Torn Material

    IT WAS REPORTED THAT THERE WAS A CRACK IN THE DEVICE. WHEN THE HOSPITAL WANTED TO USE THIS QUICKLINK FOR A PROCEDURE, THEY WERE NOT ABLE TO TURN/FIXATE THE SCREW BECAUSE THE SCREW "WIRE" WAS TORN/DAMAGED. THEREFORE, THE PROCEDURE WAS CANCELLED BY THE HOSPITAL AND THE PATIENT WAS NOT TREATED.

    Patient problems: No Patient Involvement

    MAUDE report 6817875 ↗

Other System, applicator, radionuclide, manual devices

All System, applicator, radionuclide, manual devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.