QUANTIEN™ Measurement SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067000996), received between Oct 5, 2018 and Sep 30, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Communication or Transmission Problem

  During a fractional flow reserve procedure with QUANTIEN, it was noted that the PA signals were not appearing on the monitor leading to the procedure being cancelled. There were no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952342 ↗
• MalfunctionJan 21, 2026Computer Software Problem

  DURING AN FFR PROCEDURE, WHEN ATTEMPTING TO LOG INTO THE QUANTIEN SYSTEM, IT WAS NOTED THAT THE SYSTEM HAD DISPLAYED THE ERROR MESSAGE "FAILED TO AUTHENTICATE". AN ATTEMPT WAS MADE TO LOG IN VIA THE ADMIN AND SERVICE ACCOUNTS, BUT THE ISSUE PERSISTED. SINCE THE ISSUE WAS NOT RESOLVED, THE CASE WAS ABANDONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132936 ↗
• MalfunctionMar 24, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  DURING A PROCEDURE, OUTPUT ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS REPORTED THAT WHEN IRF PRESSURE WAS SELECTED, IT WENT TO ONE SIDE AND THEN TRIED TO EQUALIZE INSTEAD OF MAINTAINING THE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676097 ↗
• MalfunctionAug 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING A PROCEDURE, THERE WAS DRIFTING CAUSING A DELAY. THE STEPS OF THE PROCEDURE WERE PERFORMED AGAIN WHICH DID NOT RESOLVE THE ISSUE. ABBOTT PERSONAL EVALUATED THE TECHNIQUE USED AT THE SITE (TIME, FLUSH, POSITIONING, EQUALIZED, ZERO), EVERYTHING WAS FINE AND ALL THE MEASUREMENT OF RFR WERE ACCURATE WITH NO DRIFT NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321598 ↗
• MalfunctionMay 5, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF A THERMAL EVENT NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14285709 ↗
• InjuryFeb 5, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, THE SYSTEM WAS SHOWING A PD INTERFACE ERROR AND THERE WAS NO CONNECTION WITH THE PRESSUREWIRE. IT TECH SUPPORT PROVIDED A LIST OF INSTRUCTIONS TO CHECK THE QUANTIEN¿S SYSTEM. UPON ASSESSMENT, IT WAS NOTED THAT A CABLE THAT HAD BEEN PULLED FROM THE REAR OF THE QUANTIEN AND INSERTED INTO THE WRONG PORT. ONCE THE CABLE WAS REMOVED AND INSERTED INTO CORRECT PORT, THE INTERFACE ERROR WAS RESOLVED. THE PROCEDURE WAS CANCELLED DUE TO THE INABILITY TO OBTAIN A READING DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285178 ↗
• InjuryNov 24, 2020Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, THE SYSTEM WAS UNABLE TO BE LOGGED INTO. THE USER ID AND PASSWORD WERE ENTERED CORRECTLY SEVERAL TIME. THE ACCOUNT THEN BECAME LOCKED AND AN ENGINEER WAS CONTACTED TO REQUEST A NEW USER ID AND PASSWORD. THE PASSWORD KEY WAS ENTERED, BUT IT WAS STILL UNABLE TO BE LOGGED INTO. HEPARIN WAS ADMINISTERED TO THE PATIENT, BUT THE PHYSIOLOGY MEASUREMENT PROCEDURE COULD NOT PROCEED. THE PROCEDURE WAS COMPLETED WITHOUT RFR MEASUREMENT WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A CLINICALLY SIGNIFICANT DELAY OCCURRED DUE TO THIS ISSUE. THE SYSTEM WAS UPDATED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10894935 ↗
• MalfunctionJan 15, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  WHILE PERFORMING A FFR CASE, A BURNING SMELL WAS NOTED AND THE POWER ADAPTER CONNECTED TO THE QUANTIEN BECAME BURNT. SMOKE WAS NOTED TO BE COMING FROM THE POWER ADAPTER AND THE SYSTEM SHUT DOWN. THE PROCEDURE WAS COMPLETED WITHOUT FFR WITH NO ADVERSE CONSEQUENCES TO THE PATIENT OR USER. THE QUANTIEN WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590937 ↗
• MalfunctionFeb 26, 2019Sparking; Sparking

  THE QUANTIEN SYSTEM COULD NOT BE TURNED ON TO VIEW A CASE BECAUSE IT WAS WET WITH CONTRAST. A SHORT CIRCUIT OCCURRED, AND A SPARK WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8369581 ↗
• MalfunctionOct 5, 2018Smoking; Smoking

  THE BLACK POWER CORD CONNECTED TO THE QUANTIEN MONITOR BEGAN TO SMOKE. THE PROCEDURE WAS IMMEDIATELY STOPPED, AND THE MONITOR WAS TURNED OFF. THE PROCEDURE WAS FINISHED WITH A NON-ABBOTT DEVICE. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7940394 ↗