Cordella Sensor Delivery Kit 100303-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00850008997006), received between Jul 29, 2024 and Sep 24, 2026 — classified as 1 death, 30 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (33 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885166 ↗
• InjurySep 16, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786350 ↗
• InjuryMar 20, 2026Incorrect Measurement

  ON 03FEB2026, THE MEDICAL AFFAIRS TEAM RECEIVED AN EMAIL FROM THE SITE REPORTING THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL WITH HEART FAILURE SECONDARY TO ATRIAL FIBRILLATION (UNRELATED TO THE CORDELLA DEVICE). THE PATIENTS CARDIOLOGIST STATED THAT THE CORDELLA SENSOR MIGHT REQUIRE RECALIBRATION, AS THE REPORTED VALUES DID NOT APPEAR TO CORRELATE WITH THE PATIENTS CLINICAL PRESENTATION. AT THAT TIME, THERE WERE NO PREVIOUS CASES INDICATING SENSOR DRIFT OR SUSPECTED DRIFT, AND THE PATIENT HAD NOT UNDERGONE ANY READER EXCHANGES OR RECALIBRATIONS. REVIEW OF THE CORDELLA DATA ACCESS PLATFORM (CDAP) AND BULK ANALYSIS SHOWED ELECTROMAGNETIC INTERFERENCE (EMI) LESS THAN 5 AND SIGNAL STRENGTH ABOVE 3600. THE PHYSICIAN REQUESTED A RIGHT HEART CATHETERIZATION AND RECALIBRATION WHILE THE PATIENT WAS ADMITTED. ON (B)(6) 2026, THE PATIENT UNDERWENT RECALIBRATION, AND THE RESULTS WERE WITHIN THE FLUID FILLED LIMITS OF AGREEMENT (FFLOA). ON (B)(6) 2026, ENDOTRONIX R&D PROVIDED THE FFLOA DETERMINATION. POST CALIBRATION FLAGS WERE NEGATIVE, WITH ONE NEGATIVE SUPINE READING ATTRIBUTED TO HIGH NOISE AND EMI. SUBSEQUENT READINGS WERE NOT NEGATIVE, AND THERE WERE NO ISSUES IDENTIFIED WITH CALI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649802 ↗
• InjuryMar 20, 2026Incorrect Measurement

  ON (B)(6) 2026 THE PATIENT UNDERWENT A RIGHT HEART CATHETERIZATION (RHC) RECALIBRATION PROCEDURE. THE SENSOR OFFSET WAS DETERMINED TO BE OUTSIDE THE ACCEPTABLE FLUID FILLED REFERENCE MEASUREMENT ERROR RANGE, CONFIRMING THAT THE SENSOR WAS PROVIDING INACCURATE MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649770 ↗
• InjuryMar 13, 2026Incorrect Measurement

  PROCEDURAL IMAGES OBTAINED DURING RHC/RECALIBRATION ON (b)(6) 2026 WERE REVIEWED. DISTAL AND PROXIMAL ANCHORS APPEARED APPROPRIATELY ATTACHED WITH THE SENSOR LOCATED IN THE RIGHT PULMONARY ARTERY.ON 30MAR2026, ADDITIONAL REVIEW OF PATIENT DATA (BY EDWARDS LIFESCIENCES) DID NOT RAISE CONCERN OF ANY DEVICE ISSUES. IT WAS NOTED THAT THE PATIENT MAY HAVE TAKEN SOME READINGS IN THE RECLINED/SUPINE POSITION BUT MARKED AS SEATED. THE FREQUENCY OF READINGS AND NUMBER OF READINGS THAT SHOWED INCREASED THETA ARE NOT SUSPECTED TO HAVE DRASTICALLY SHIFTED MPAP TRENDS. ADDITIONALLY, SOME READINGS HAD NOTED "NOISE" SPIKES BUT WERE NOT EXPECTED TO IMPACT PULMONARY ARTERY PRESSURE VALUES.ADDITIONAL PATIENT HISTORY WAS RECEIVED. THE PATIENT WAS REPORTEDLY CHRONICALLY ILL AND HAD BEEN HOSPITALIZED FOR MONTHS PRIOR TO IMPLANT. (b)(6) HAD BEEN IMPLANTED DURING HOSPITALIZATION AS THE PHYSICIAN FELT THE PATIENT WAS NOT STABLE ENOUGH TO GET DISCHARGED HOME AND REMAIN OUT OF THE HOSPITAL LONG ENOUGH TO GET SCHEDULED AS AN OUTPATIENT. THERE WAS ADDITIONAL DISCUSSION/DECISION FOR TREATMENT REGARDING LVAD/TRANSPLANT HOWEVER, THE PATIENT WAS NOT A CANDIDATE DUE TO WEIGHT AND OTHER UNREPORTED FACTORS.ULTIMATEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594086 ↗
• InjuryMar 3, 2026Incorrect Measurement

  DURING (B)(6) 2025 PROACTIVE MONITORING BY ENDOTRONIX, SUSPECTED SENSOR DRIFT WAS IDENTIFIED AND THE SITE WAS NOTIFIED TO PAUSE USE OF PA READINGS AS A PARAMETER FOR DETERMINING PATIENT TREATMENT. ON (B)(6) 2025, IT WAS RECOMMENDED THAT THE PATIENT UNDERGO 3-YEAR SCHEDULED RECALIBRATION. ON (B)(6) 2026, PATIENT RECALIBRATION WAS COMPLETED SUCCESSFULLY FOLLOWED BY MONITORING AND ASSESSMENT OF THE PATIENT DATA. ON (B)(6) 2026, ENDOTRONIX CONFIRMED SENSOR ACCURACY AND CONCLUDED THAT THERE WERE NO CONCERNS WITH THE CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500284 ↗
• InjuryFeb 27, 2026Incorrect Measurement

  DURING (B)(6) 2025 PROACTIVE MONITORING BY ENDOTRONIX, SUSPECTED SENSOR DRIFT WAS IDENTIFIED AND THE SITE WAS NOTIFIED TO PAUSE USE OF PA READINGS AS A PARAMETER FOR DETERMINING PATIENT TREATMENT. ON (B)(6) 2025, IT WAS RECOMMENDED THAT THE PATIENT UNDERGO 3-YEAR SCHEDULED RECALIBRATION. ON (B)(6) 2026, PATIENT RECALIBRATION WAS COMPLETED SUCCESSFULLY FOLLOWED BY MONITORING AND ASSESSMENT OF THE PATIENT DATA. ON (B)(6) 2026, ENDOTRONIX CONFIRMED THE SENSOR DRIFT INITIALLY SUSPECTED IN (B)(6) 2025 AND CONCLUDED THAT THERE WERE NO CONCERNS WITH THE CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474368 ↗
• InjuryJan 29, 2026Incorrect Measurement

  THE PATIENT WAS SCHEDULED FOR A THREE-YEAR RIGHT HEART CATHETERIZATION (RHC) WITH SENSOR RECALIBRATION ON (B)(6) 2026. PRIOR TO THE PROCEDURE, THE PATIENTS' DATA WAS REVIEWED INDICATING MEAN PULMONARY ARTERY PRESSURE AND PULMONARY PRESSURE DIVERGENCE FROM THE INITIAL RELATIONSHIP AT THE TIME OF IMPLANT. RHC WITH RECALIBRATION WAS COMPLETED ON (B)(6) 2026 REQUIRING A PRESSURE ADJUSTMENT OF ONLY 0.5MMHG AND SENSOR ACCURACY WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209175 ↗
• InjuryDec 16, 2025Incorrect Measurement; Incorrect Measurement

  ON (B)(6) 2023, PRIOR TO DEVICE COMMERCIALIZATION, ENDOTRONIX (ETX) SUSPECTED SENSOR INACCURACY WAS IDENTIFIEDS DURING PROACTIVE MONITORING AND RECOMMENDED AN UNSCHEDULED RECALIBRATION; HOWEVER, THE SITE WAS UNRESPONSIVE. MULTIPLE RECALIBRATION RECOMMENDATIONS WERE ISSUED THROUGHOUT 2024, AND THE PATIENT LATER UNDERWENT AN UNSCHEDULED RECALIBRATION ON (B)(6) 2024, WITH RESULTS OUTSIDE THE FLUID FILLED LIMITS OF AGREEMENT (FFLOA). AS OF (B)(6) 2025, THE PATIENT IS CLINICALLY STABLE AND TAKING READINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816390 ↗
• MalfunctionDec 2, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, A SENSOR WAS DEPLOYED IN THE ANTERIOR POSITION FOR A PATIENT. INITIAL CALIBRATION ATTEMPTS YIELDED A SIGNAL STRENGTH OF 85%, THOUGH INTERFERENCE REQUIRED MITIGATION. SUBSEQUENT ATTEMPTS FAILED TO REACH THE 80% THRESHOLD NECESSARY FOR LOCKING. AFTER APPROXIMATELY 10 MINUTES, THE PHYSICIAN PERFORMED FLUOROSCOPY, REVEALING THAT THE SENSOR HAD SHIFTED DISTALLY AND ROTATED TOWARD THE COLLARBONE. POST-OPERATIVELY, CALIBRATION ATTEMPTS FROM THE CHEST USING AN ALLOY READER WERE UNSUCCESSFUL DUE TO THE PATIENT'S BODY SIZE AND BREATHING PATTERN, WHICH CAUSED FLUCTUATING SIGNAL STRENGTH BELOW 80%. CALIBRATION WAS ULTIMATELY ACHIEVED FROM THE PATIENT'S BACK, WITH SEATED READINGS REACHING APPROXIMATELY 85%, THOUGH SIGNAL STRENGTH REMAINED UNSTABLE. THE PATIENT WAS DISCHARGED WITH THE ALLOY READER BUT WAS UNABLE TO PERFORM READINGS WITHOUT ASSISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693966 ↗
• InjuryNov 26, 2025Failure to Sense; Failure to Sense

  MYCORDELLA SUPPORT TEAM (MST) REPORTED THE PATIENT WAS TAKING READINGS SUCCESSFULLY AS OF (b)(6) 2025 AND STOPPED AS OF (b)(6) 2026, WHEN THE PATIENT WAS PLACED ON HOSPICE CARE SECONDARY TO CHRONIC HEART FAILURE (UNRELATED TO THE CORDELLA DEVICE).

  Patient problems: Insufficient Information

  MAUDE report 23659367 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-IMPLANT OF A CORDELLA SENSOR ON (B)(6) 2025, THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE AS MANUAL COMPRESSION WAS HELD AT THE ACCESS SITE (JUGULAR ACCESS). A CT SCAN WAS PERFORMED TO RULE OUT COMPLICATIONS SUCH AS STROKE OR RETROPERITONEAL BLEEDING (RP), AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING. BY (B)(6) 2025, REPORTS INDICATED THAT THE PATIENT HAD RETURNED TO BASELINE WITH NO SIGNS OF STROKE OR RETROPERITONEAL BLEED. THE PHYSICIAN LATER CONFIRMED THE PATIENT HAD BLED INTO THE PLEURAL SPACE DUE TO A CHALLENGING NECK ACCESS BUT WAS STABLE AND BREATHING ROOM AIR. THE PATIENT EXITED THE INTENSIVE CARE UNIT BY (B)(6) 2025 AND WAS DISCHARGED HOME BY (B)(6) 2025 WHEN POST-IMPLANT TRAINING WITH THE CORDELLA SYSTEM WAS SUCCESSFULLY COMPLETED.

  Patient problems: Hemothorax

  MAUDE report 23658010 ↗
• MalfunctionAug 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025, THE CLINIC CONTACTED THE MANUFACTURER INQUIRING ABOUT POTENTIAL DRIFT/INACCURACY OF THE MYCORDELLA SENSOR THAT HAD BEEN IMPLANTED IN THE PATIENT. AN ASSESSMENT AT THE TIME OF THE INITIAL REPORT NOTED NO EVIDENCE OF DRIFT AND THE CLINICAL SITE WAS INFORMED. ON (B)(6) 2025 DURING PROACTIVE MONITORING BY THE MANUFACTURER, POTENTIAL SENSOR DRIFT/INACCURACY WAS NOTED. THE CLINICAL SITE WAS INFORMED, AND RIGHT HEART CATHETERIZATION (RHC) WAS RECOMMENDED TO RECALIBRATE THE MYCORDELLA SENSOR. AS OF 15-AUG-2025, THE RHC HAD NOT BEEN COMPLETED. ADDITIONAL ATTEMPTS TO GATHER INFORMATION ARE ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22888455 ↗
• MalfunctionAug 13, 2025Failure to Sense; Failure to Sense

  FOLLOWING SUCCESSFUL IMPLANT OF THE SENSOR, THE READER WAS NOT ABLE TO DETECT A SIGNAL LOCK ON TO AND CALIBRATE THE SENSOR. AFTER MULTIPLE ATTEMPTS AND TROUBLESHOOTING, IT WAS DETERMINED THAT THE SENSOR HAD FAILED. DESPITE THESE ISSUES, THE PATIENT REMAINS CLINICALLY STABLE WITH NO CLINICAL CONSEQUENCES AND CONTINUES TO TAKE DAILY VITAL SIGN (BP, PULSE OXIMETRY AND WEIGHT) READINGS UTILIZING THE CORDELLA HEART FAILURE SYSTEM (CHFS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792968 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHORTLY AFTER DEVICE IMPLANTATION, THE PATIENT EXPERIENCED COUGHING AND HEMOPTYSIS, ALONG WITH MILD SHORTNESS OF BREATH. THESE SYMPTOMS WERE ADDRESSED DURING HOSPITALIZATION, AND THE PATIENT HAS SINCE RECOVERED AND BEEN DISCHARGED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Hemoptysis

  MAUDE report 22581708 ↗
• MalfunctionJul 23, 2025Incorrect Measurement; Incorrect Measurement

  THE SITE SUSPECTED SENSOR INACCURACY AND THE PATIENT WAS REVIEWED BY ENDOTRONIX'S INTERNAL MONITORING WHERE IT WAS DETERMINED THAT THIS PATIENT IS SUSPECTED FOR SENSOR INACCURACY. THE CLINICAL SPECIALIST (CS) EMAILED THE SITE COORDINATOR LETTING THEM KNOW TO STOP TREATING BASED ON MPAP. THE PATIENT WILL BE SCHEDULED FOR RECALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581705 ↗
• InjuryJun 25, 2025Incorrect Measurement; Incorrect Measurement

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT UNDERWENT 3-YEAR RECALIBRATION. A RIGHT HEART CATHETERIZATION (RHC) WAS PERFORMED TO CONFIRM THE ACCURACY OF THE PRESSURE SENSOR AGAINST A REFERENCE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330708 ↗
• InjuryJun 25, 2025Incorrect Measurement; Incorrect Measurement

  PATIENT UNDERWENT RIGHT HEART CATHETERIZATION (RCH) AND RECALIBRATION ON (B)(6) 2025. THE CALIBRATION RESULTS ARE CURRENTLY UNDER REVIEW TO DETERMINE IF THE SENSOR WAS OPERATING WITHIN THE ACCEPTABLE ACCURACY RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330707 ↗
• InjuryJun 25, 2025Incorrect Measurement; Incorrect Measurement

  THE SITE SUSPECTED SENSOR INACCURACY. THE PATIENT UNDERWENT AN UNSCHEDULED RECALIBRATION, AND A RIGHT HEART CATHETERIZATION (RHC) WAS PERFORMED TO CONFIRM THE ACCURACY OF THE PRESSURE SENSOR AGAINST A REFERENCE PRESSURE. THE SENSOR WAS FOUND TO BE OUTSIDE THE RANGE OF ACCURACY; THEREFORE, A RECALIBRATION ADJUSTMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330705 ↗
• DeathJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SUCCESSFULLY IMPLANTED WITH CORDELLA PULMONARY ARTERY SENSOR. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. SEVERAL HOURS LATER, THE PATIENT CODED AND EXPIRED IN ICU.

  Patient problems: Cardiac Arrest

  MAUDE report 22290115 ↗
• InjuryJun 4, 2025Incorrect Measurement; Incorrect Measurement

  SENSOR INACCURACY SUSPECTED. PATIENT WILL UNDERGO UNSCHEDULED RECALIBRATION TO DETERMINE IF AN ADJUSTMENT IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141125 ↗
• MalfunctionMay 22, 2025Incorrect Measurement; Incorrect Measurement

  THE PATIENT WAS REVIEWED BY ENDOTRONIX'S INTERNAL MONITORING WHERE IT WAS DETERMINED THAT THIS PATIENT IS SUSPECTED FOR SENSOR INACCURACY. THE CLINICAL SPECIALIST (CS) EMAILED THE SITE COORDINATOR LETTING THEM KNOW TO STOP TREATING BASED ON MPAP AND ENDOTRONIX R&D WILL CONTINUE TO MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070601 ↗
• InjuryMay 15, 2025Incorrect Measurement; Incorrect Measurement

  THE PATIENT WAS REVIEWED BY ENDOTRONIX'S INTERNAL MONITORING WHERE IT WAS DETERMINED THAT THIS PATIENT IS SUSPECTED OF SENSOR INACCURACY. THE PATIENT WILL UNDERGO RECALIBRATION ON (B)(6) 2025, TO DETERMINE IF AN ADJUSTMENT IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030428 ↗
• MalfunctionMay 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE SITE REPORTED SUSPECTED SENSOR INACCURACY. THE PATIENT HAD A SENSOR RECALIBRATION ON (B)(6) 2025. A RIGHT HEART CATHETERIZATION (RHC) WAS PERFORMED TO CONFIRM THE ACCURACY OF THE PRESSURE SENSOR AGAINST A REFERENCE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029711 ↗
• InjuryApr 28, 2025Incorrect Measurement; Incorrect Measurement

  THE PATIENT WAS REVIEWED BY ENDOTRONIX'S INTERNAL MONITORING WHERE IT WAS DETERMINED THAT THIS PATIENT IS SUSPECTED FOR SENSOR INACCURACY. THE CLINICAL SPECIALIST (CS) EMAILED THE SITE COORDINATOR LETTING THEM KNOW TO STOP TREATING BASED ON MPAP AND TO SCHEDULE A RECALIBRATION. PATIENT WILL UNDERGO REGULARLY SCHEDULED 3-YEAR RECALIBRATION ON (B)(6) 2025 TO DETERMINE IF AN ADJUSTMENT IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919158 ↗