Artisan Link Pro AR310Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 05700571108451), received between Sep 9, 2020 and Jul 10, 2026 — classified as 1 injury, 89 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (35 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

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Fire; Smoking

  A UNITED KINGDOM CUSTOMER REPORTED THAT THEIR ARTISAN INSTRUMENT WAS NOT ADEQUATELY DE-WAXING SLIDES. A FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND PROVIDED GUIDANCE ON CHECKING THE INSTRUMENT'S HEATERS. THE CUSTOMER ELECTED TO PERFORM THE HEATER CHECKS INDIVIDUALLY AND INDICATED THEY WOULD FOLLOW UP WITH THE FIELD SERVICE ENGINEER (FSE) UPON COMPLETION. AFTER COMPLETING THE HEATER CHECKS, THE CUSTOMER REPORTED THAT DURING TESTING THEY HEARD A "POP," FOLLOWED BY SMOKE AND VISIBLE FLAMES ORIGINATING FROM THE INSTRUMENT. A CO2 FIRE EXTINGUISHER WAS USED TO EXTINGUISH THE FLAMES, AND THE FIRE BRIGADE WAS CONTACTED. THE CUSTOMER WAS ADVISED TO NOT POWER-ON THE INSTRUMENT. THE FSE WENT TO THE CUSTOMER'S SITE TO INSPECT THE INSTRUMENT AND DETERMINED THAT UPON INSPECTION, EVIDENCE OF A SHORT CIRCUIT ON THE HEATER CONTROL BOARD WAS IDENTIFIED, INCLUDING VISIBLE SCORCH MARKS. LIQUID RESIDUE WAS ALSO OBSERVED ON THE HEATER BOARDS AND ASSOCIATED CABLING. THE FSE REMOVED THE REAR PANEL FOR FURTHER EXAMINATION OF THE INSTRUMENT AND COULDN'T FIND ANYTHING OUT OF PLACE OR ON ANY OF THE PANELS. THE INSTRUMENT WAS TAKEN OUT OF SERVICE, AND THE ARTISAN INSTRUMENT WAS DEEMED NON-REPAIRABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25782466 ↗
• MalfunctionNov 6, 2025Device Remains Activated; Excessive Heating; Device Remains Activated; Excessive Heating

  THE CUSTOMER REPORTED THAT THE FIRST SLIDE POSITION OF THE INSTRUMENT WAS HOT TO THE TOUCH WHILE THE INSTRUMENT WAS NOT IN USE. IT WAS CONFIRMED THAT ONLY THE FIRST SLIDE POSITION WAS AFFECTED BY THE ISSUE. AN AGILENT FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO SERVICE THE INSTRUMENT BUT WAS UNABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE, AS UPON INSPECTION THE HEATER REMAINED COLD AND UNABLE TO OPERATE. IT WAS FOUND THAT THE HEATER CABLES HAD SHORTED CAUSING THE THERMAL FUSE TO BE TRIGGERED RESULTING IN THE HEATER BEING DISABLED. THE FSE REPLACED ALL REQUIRED COMPONENTS. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. WHILE THERE WAS NO DIRECT OR INDIRECT USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488557 ↗
• MalfunctionOct 31, 2025Leak/Splash; Device Remains Activated; Excessive Heating; Leak/Splash; Device Remains Activated; Excessive Heating

  THE CUSTOMER REPORTED DIRTY INCONSISTENT STAINING AND THAT THEY HAVE DISCONTINUED USING POSITIONS 9-16 ON THE INSTRUMENT AS THE HEAT REQUIRED STAINS ARE NOT TURNING OUT WELL IN THOSE POSITIONS. ON AN UNKNOWN DATE, THE BULK WASTE WAS NOT EMPTIED WHICH OVERFLOWED ONTO THE CLIPS AND SPILL TRAY. THE CUSTOMER NOTICED THAT ALL THE SUBSEQUENT SLIDES WERE COMING OUT DIRTY OR WITH WEAK STAINING. THE CUSTOMER ALSO MENTIONED THAT POSITIONS 9 AND 23 DID NOT COOL DOWN AFTER THE RUN WAS COMPLETED. THIS WAS DISCOVERED WHEN THE CUSTOMER WAS CLEANING THE PADS WITH A WET GAUZE PAD. AN AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND VERIFIED THAT DUE TO THE OVERFLOW IN THE INSTRUMENT, THE HEATER BOARDS AND HEATERS WERE NO LONGER WORKING. THE FSE REPLACED ALL REQUIRED COMPONENTS. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. REAGENT OR LIQUID SPILLING ONTO THE HEATER CONTROL BOARD HAS THE POTENTIAL TO SHORT CIRCUIT THE HEATER CONTROL BOARD AND NOT PROVIDE ACCURATE DATA FLOW AND SIGNAL TRANSMISSION TO THE RESPECTIVE HEATER PLATES CAUSING THEM TO REMAIN ON WHEN UNINTENDED. WHILE THERE WAS NO DIRECT OR INDIRECT USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435986 ↗
• MalfunctionOct 17, 2025Leak/Splash; Device Remains Activated; Excessive Heating; Leak/Splash; Device Remains Activated; Excessive Heating

  WHILE ON-SITE ADDRESSING AN ASPIRATION-RELATED ISSUE, THE AGILENT FIELD SERVICE ENGINEER (FSE) FOUND THAT THE HEATERS FOR SLIDE POSITIONS 2-5 AND 12-16 WERE CONSISTENTLY STAYING ON WHEN THE ARTISAN INSTRUMENT WAS IDLE. THESE HEATERS WERE REMAINING ACTIVE AS HEATER CONTROL BOARDS 1 AND 2 HAD BEEN DAMAGED BY A DEFECTIVE VACUUM PUMP WHICH WAS INCORRECTLY ASPIRATING. THE FSE SERVICED THE INSTRUMENT BY REPLACING THE HEATER CONTROL BOARDS AND ALL REQUIRED COMPONENTS. AFTER REPAIR, THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO RECUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330813 ↗
• MalfunctionMay 6, 2025Leak/Splash; Device Remains Activated; Excessive Heating; Leak/Splash; Device Remains Activated; Excessive Heating

  A CUSTOMER IN THE UNITED STATES REPORTED THAT MULTIPLE HEATING ELEMENTS ON THE ARTISAN INSTRUMENT WERE STAYING ON AFTER A RUN WAS COMPLETED ON (B)(6) 2025. AN AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND VERIFIED THE CUSTOMER'S COMPLAINT. 42 HEATERS HAD SHORT CIRCUITED DUE TO AN ASPIRATION ISSUE WHICH CAUSED REAGENT TO OVERFLOW ONTO A HEATER CONTROL BOARD. THE FSE REPLACED THE 42 HEATERS AND ALL REQUIRED COMPONENTS. THE INSTRUMENT IS FULLY OPERATIONAL AND READY FOR USE. TESTING WAS ABLE TO BE COMPLETED WITH ANOTHER INSTRUMENT. REAGENT SPILLING ONTO THE HEATER CONTROL BOARD HAS THE POTENTIAL TO SHORT CIRCUIT THE HEATER CONTROL BOARD AND NOT PROVIDE ACCURATE DATA FLOW AND SIGNAL TRANSMISSION TO THE RESPECTIVE HEATER PLATES CAUSING THEM TO REMAIN ON WHEN UNINTENDED. WHILE THERE WAS NO DIRECT, OR INDIRECT, USER HARM REPORTED FOR THIS EVENT; IT IS BEING REPORTED DUE TO THE POTENTIAL FOR HARM IF THE EVENT WERE TO REOCCUR. THEREFORE, THIS REPORT IS BEING FILED AS PART OF AGILENT'S COMMITMENT TO DUE DILIGENCE REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967022 ↗
• MalfunctionJan 24, 2025Device Remains Activated; Excessive Heating; Device Remains Activated; Excessive Heating

  THE CUSTOMER CONTACTED AN AGILENT FIELD SERVICE ENGINEER (FSE) AND REPORTED THAT HEATER PLATE POSITIONS 41-48 APPEAR TO REMAIN HEATED AFTER THE RUN HAS COMPLETED. FSE INSPECTED THE INSTRUMENT AND FOUND THAT THE VACUUM PUMP WAS INOPERABLE CAUSING NO REAGENT ASPIRATION DURING A STAINING RUN. THIS CAUSED THE INSTRUMENT TO LEAK OVER MULTIPLE HEATER BOARDS AND HEATER PLATES RESULTING IN HEATER 41-48 TO REMAIN ACTIVE POST STAINING RUN. FSE REPLACED THE AFFECTED HEATER BOARDS AND HEATER PLATES. THE INSTRUMENT HAS BEEN REPAIRED, IT IS FULLY OPERATIONAL AND IS AVAILABLE TO THE USER. NO USER HARM WAS INDICATED. THE CUSTOMER WAS ABLE TO COMPLETE STAINING WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228756 ↗
• MalfunctionDec 31, 2024Unintended Power Up; Overheating of Device; Excessive Heating; Unintended Power Up; Overheating of Device; Excessive Heating

  THE UNITED STATES OF AMERICA CUSTOMER REPORTED THE ARTISAN INSTRUMENT'S HEATER PLATES WERE TURNING ON AND STAYING ON EVEN WHEN NOT IN USE, CAUSING THE INSTRUMENT ITSELF TO BE HOT TO THE TOUCH. THE USER ACCIDENTALLY BURNED TWO FINGERS ON THEIR LEFT HAND, THE MIDDLE AND RING FINGERS, WHEN ROTATING THE ARTISAN SLIDE CAROUSEL. THE BURN CAUSED BLISTERS ON THE USER'S FINGERTIPS. THE USER DID NOT SEEK MEDICAL TREATMENT HOWEVER, THE USER DID RUN WATER OVER THEIR FINGERS AND THEN APPLIED ICE. AN INTERNAL INJURY REPORT WAS LOGGED WITH THE USER FACILITY. IT WAS NOTED THE USER HAD LIMITED USE OF THEIR HAND THAT DAY AND WAS NOT ABLE TO SECTION TISSUE BLOCKS ON THE MICROTOME. IT WAS CONFIRMED THE USER DIDN'T SEEK ADDITIONAL MEDICAL INTERVENTION OR TREATMENT SINCE THE TIME OF THE INCIDENT. THE USER IS NO LONGER LIMITED IN THE USER OF THEIR HAND AND THE FINGERS ARE "NEARLY HEALED". THE CUSTOMER NOTES THE USER BURNED THEIR FINGERS ON HEATER POSITION 48 AND POSSIBLY 47. THE AGILENT FIELD SERVICE ENGINEER (FSE) SERVICED THE INSTRUMENT AND NOTED, WHEN POWERING ON THE ARTISAN USING THE PHYSICAL SWITCH, HEATERS 25-48 WOULD ACTIVATE. THE FSE REPLACED THE HEATER CONTROL BOARDS UNDERNEATH HEATERS 25-48, AN

  Patient problems: Blister; Partial thickness (Second Degree) Burn

  MAUDE report 21048523 ↗
• MalfunctionNov 30, 2023Fire; Smoking; Fire; Smoking

  THE SPAIN CUSTOMER REPORTED "HEATERS ARE BURNT." AGILENT FIELD SERVICE ENGINEER STATES THAT SOME HEATER CONTROL BOARDS, HEATERS AND CABLES SUFFERED DAMAGE AND EMITTED FLAMES WITH SMOKE WHILE THE INSTRUMENT WAS IN OPERATION. FSE SERVICED THE INSTRUMENT WITH REPLACEMENT OF AFFECTED PARTS AND CONFIRMS THAT THE SAMPLES WERE NOT AFFECTED AND ALL USERS AND SURROUNDING ITEMS NEAR THE INSTRUMENT WERE SAFE FROM ANY HARM. INSTRUMENT IS RUNNING AND THE CUSTOMER WAS ABLE TO COMPLETE TESTING. DIAGNOSTICS WERE NOT ALTERED. THERE WAS NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243485 ↗
• InjuryJan 25, 2023Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  THE UNITED STATES OF AMERICA CUSTOMER REPORTED "THE ARTISAN LINK PRO FAILED TO ASPIRATE THE WASTE FLUIDS FROM THE SLIDE CLIPS AND WASH BASIN AT THE END OF THE RUN. IT APPEARS THAT THIS OCCURRED THROUGHOUT THE RUN AS THE DRIP PAN WAS FLOODED. ALTHOUGH THE LAB HAS A SECOND ARTISAN, THE SLIDES CANNOT BE REPEATED SINCE THESE WERE KIDNEY SECTIONS AND THE BLOCKS CANNOT BE RECUT. PATIENT IMPACT IS UNKNOWN. 18 SLIDES WERE IMPACTED (3 CASES OF PATIENT TRANSPLANT KIDNEY BIOPSIES)". THE FIELD SERVICE ENGINEER REPAIRED THE INSTRUMENT BY REPLACING THE PUMP ASSEMBLY AND WASTE MANIFOLD WHICH RESOLVED THIS MALFUNCTION. IT IS UNKNOWN IF TESTING WAS ABLE TO BE COMPLETED AND IF THE PATIENT WILL NEED A RE-BIOPSY. MORE THAN 3 GOOD FAITH EFFORTS WERE MADE TO CONTACT THE CUSTOMER WITH NO ANSWER TO THESE ISSUES. THERE WAS NO DIRECT OR INDIRECT USER HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16240940 ↗
• MalfunctionJun 22, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: SOME HEATERS ARE DAMAGED. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044270 ↗
• MalfunctionJun 22, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: HEATERS DO NOT REACH TEMPERATURE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044252 ↗
• MalfunctionJun 4, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: HEATER 31 NOT HEATING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941359 ↗
• MalfunctionMay 20, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: HEATER PROBLEM DURING DEWAXING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856209 ↗
• MalfunctionMay 13, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: TWO HEATER PLATES NOT REACHING TEMPERATURE. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819505 ↗
• MalfunctionMay 13, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: HEATER NUMBER 1 AND 2 BROKEN. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819463 ↗
• MalfunctionMay 12, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: SLIDE PLATES 2, 5, 13 NOT HEATING NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813907 ↗
• MalfunctionFeb 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: WEAK GMS STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378362 ↗
• MalfunctionFeb 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378357 ↗
• MalfunctionFeb 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: GMS INCONSISTENT STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378336 ↗
• MalfunctionFeb 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: BLOTCHY STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378332 ↗
• MalfunctionFeb 25, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: STAINING ISSUE NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378128 ↗
• MalfunctionFeb 25, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS:INCONSISTENT STAINING NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378125 ↗
• MalfunctionFeb 25, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378122 ↗
• MalfunctionFeb 25, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: INCONSISTENT STAINING NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378116 ↗
• MalfunctionFeb 25, 2021Mechanical Problem; Mechanical Problem

  CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: LIGHT STAINING NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378108 ↗