MITROFLOWRecalls & reported problems across all models

We found 10 models of MITROFLOW by Corcym Canada Corp in the FDA's device registry (GUDID). Together they are named in 227 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2016 and Oct 11, 2024 — classified as 30 deaths, 192 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (96 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MITROFLOW problems

MITROFLOW models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MITROFLOW DLA23

  heart-valve, non-allograft tissue
  7 deaths44 reports
• MITROFLOW DLA21

  heart-valve, non-allograft tissue
  5 deaths42 reports
• MITROFLOW LXA23

  heart-valve, non-allograft tissue
  1 death34 reports
• MITROFLOW LXA21

  heart-valve, non-allograft tissue
  5 deaths27 reports
• MITROFLOW DLA25

  heart-valve, non-allograft tissue
  2 deaths21 reports
• MITROFLOW LXA25

  heart-valve, non-allograft tissue
  2 deaths19 reports
• MITROFLOW LXA19

  heart-valve, non-allograft tissue
  4 deaths16 reports
• MITROFLOW DLA19

  heart-valve, non-allograft tissue
  3 deaths12 reports
• MITROFLOW DLA27

  heart-valve, non-allograft tissue
  1 death7 reports
• MITROFLOW LXA27

  heart-valve, non-allograft tissue
  5 reports

Recent MITROFLOW adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURE WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED FROM PATIENT IMPLANT FORM, A DLA23 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2016. REPORTEDLY, PATIENT DECEASED ON (B)(6) 2016. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20434057 ↗
• DeathOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURE WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED FROM PATIENT IMPLANT FORM, A DLA23 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2016. REPORTEDLY, PATIENT DECEASED ON (B)(6) 2016. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20433708 ↗
• DeathMay 1, 2024Degraded; Degraded

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A PATIENT WHO HAD A MITROFLOW VALVE LXA21 IMPLANTED ON (B)(6) 2013, WAS UNDER EVALUATION FOR TAVR DUE TO AORTIC STENOSIS. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT HAD A PMH OF BIOPROTHTETIC SAVR AND MITRAL ANNULOPLASTY RING IN 2013. THERE WAS PERSISTENT AFIB WITH CHA2DS2-VASC SCORE OF 4, VT, BIV ICD (B)(6) ORIGINAL IN (B)(6) 2013 AND UPGRADE TO BOSTON SCIENTIFIC IN (B)(6) 2023 ((B)(6) =LEAD TO RV REMAINS). REPORTEDLY, PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2024 WITH INCREASING BILATERAL LE SWELLING AND PAIN TO LEGS FOR A COUPLE DAYS. PATIENT WAS FOUND TO BE IN ACUTE CHRONIC DECOMPENSATED HEART FAILURE WITH BNP (B)(4), NEG TROP OF 32, CREAT 2.2 AND LACTIC ACID 1.2. PATIENT THEN WAS ADMITTED TO THE ICU. PATIENT'S TSH WAS NOTABLY HIGH AND FREE T3/T4 WAS LOW. PATIENT WAS SEEN BY ENDOCRINE FOR A DIFFERENTIAL OF MYXEDEMA COMA AND ADRENAL INSUFFICIENCY AND GIVEN IV SYNTHROID AND HYDROCORTISONE. PATIENT THEN REMAINED ON PRESSORS AND WAS TRANSFERRED TO IFH WITH MIXED CARDIOGENIC/METABOLIC SHOCK AND WAS FOUND TO HAVE SEVERE STENOSIS OF BOTH AORTIC AND MITRAL VALVES. AS SUCH, DUE TO

  Patient problems: Aortic Valve Stenosis; Mitral Valve Stenosis

  MAUDE report 19225518 ↗
• DeathMay 1, 2024Degraded; Degraded

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A PATIENT WHO HAD A MITROFLOW VALVE LXA21 IMPLANTED ON (B)(6) 2013, WAS UNDER EVALUATION FOR TAVR DUE TO AORTIC STENOSIS. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT HAD A PMH OF BIOPROTHTETIC SAVR AND MITRAL ANNULOPLASTY RING IN 2013. THERE WAS PERSISTENT AFIB WITH CHA2DS2-VASC SCORE OF 4, VT, BIV ICD ST JUDE ORIGINAL IN (B)(6) 2013 AND UPGRADE TO BOSTON SCIENTIFIC IN (B)(6) 2023 (ST JUDE =LEAD TO RV REMAINS). REPORTEDLY, PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2024 WITH INCREASING BILATERAL LE SWELLING AND PAIN TO LEGS FOR A COUPLE DAYS. PATIENT WAS FOUND TO BE IN ACUTE CHRONIC DECOMPENSATED HEART FAILURE WITH BNP 13,917, NEG TROP OF 32, CREAT 2.2 AND LACTIC ACID 1.2. PATIENT THEN WAS ADMITTED TO THE ICU. PATIENT'S TSH WAS NOTABLY HIGH AND FREE T3/T4 WAS LOW. PATIENT WAS SEEN BY ENDOCRINE FOR A DIFFERENTIAL OF MYXEDEMA COMA AND ADRENAL INSUFFICIENCY AND GIVEN IV SYNTHROID AND HYDROCORTISONE. PATIENT THEN REMAINED ON PRESSORS AND WAS TRANSFERRED TO IFH WITH MIXED CARDIOGENIC/METABOLIC SHOCK AND WAS FOUND TO HAVE SEVERE STENOSIS OF BOTH AORTIC AND MITRAL VALVES. AS SUCH, DUE

  Patient problems: Aortic Valve Stenosis

  MAUDE report 19225507 ↗
• InjuryOct 19, 2022Degraded; Degraded

  THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO HAD A MITROFLOW AORTIC PERICARDIAL VALVE LXA19 IMPLANTED ON (B)(6) 2013, DUE TO AORTIC ROOT ANEURYSM WITH AORTIC REGURGITATION WITH CONNECTIVE TISSUE DISORDER, DEVELOPED A PROGRESSIVE AORTIC STENOSIS AND MITRAL REGURGITATION. ON (B)(6) 2015, SHE UNDERWENT A RE-DO STERNOTOMY TO REPLACE THE MITROFLOW VALVE WITH A 19 MM MAGNA EASE. AS REPORTED, PATIENT DIED ON (B)(6) 2021 DUE TO SYSTOLIC HEART FAILURE DUE TO DIASTOLIC HEART FAILURE DUE TO VALVE (MAGNA EASE) DYSFUNCTION.

  Patient problems: Aortic Valve Stenosis; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15633928 ↗
• InjuryJun 23, 2022Degraded; Degraded

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION PROVIDED, A PATIENT WAS SCHEDULED TO UNDERGO A TAVR ON (B)(6) OR (B)(6) 2022. THE PATIENT RECEIVED A MITROFLOW VALVE LXA23 ON (B)(6) 2012 IN AORTIC POSITION. THE DAY BEFORE THE TAVR PROCEDURE, THE PATIENT HAD A MASSIVE STOKE. THE PATIENT SURVIVED, BUT IS NO LONGER SUITABLE FOR THE PROCEDURE. THE PATIENT HAD VALVE FAILURE DUE TO STENOSIS. THE PATIENT WAS TRANSFERRED TO A HOSPICE CARE.

  Patient problems: Aortic Valve Stenosis; Stroke/CVA

  MAUDE report 14791432 ↗
• InjuryJun 23, 2022Degraded; Degraded

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION PROVIDED, A PATIENT WAS SCHEDULED TO UNDERGO A TAVR ON (B)(6) OR (B)(6) 2022. THE PATIENT RECEIVED A MITROFLOW VALVE LXA23 ON (B)(6) 2012 IN AORTIC POSITION. THE DAY BEFORE THE TAVR PROCEDURE, THE PATIENT HAD A MASSIVE STOKE. THE PATIENT SURVIVED, BUT IS NO LONGER SUITABLE FOR THE PROCEDURE. THE PATIENT HAD VALVE FAILURE DUE TO STENOSIS. THE PATIENT WAS TRANSFERRED TO A HOSPICE CARE.

  Patient problems: Aortic Valve Stenosis; Fatigue; Stroke/CVA

  MAUDE report 14791415 ↗
• InjuryJan 28, 2022Calcified; Calcified

  ON (B)(6) 2012, A PATIENT RECEIVED A MITROFLOW VALVE SIZE 19 AS PART OF AN AORTIC VALVE REPLACEMENT PROCEDURE. THE PATIENT¿S PREOPERATIVE DIAGNOSIS WAS OF NATIVE AORTIC VALVE STENOSIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITIONS. THE ECHO PERFORMED IN (B)(6) 2012 SHOWED A MITROFLOW VALVE ADEQUATELY FUNCTIONING (MEAN/PEAK GRADIENTS 26/45MMHG, TRACE OF AORTIC VALVE REGURGITATION). MILD MITRAL REGURGITATION IS NOTED, WITH MILD-MODERATE MITRAL ANNULAR REGURGITATION. THE LEFT VENTRICULAR WALL THICKNESS IS MILDLY INCREASED (EF IS 55-60%). THE ECHO PERFORMED IN (B)(6) 2014 SHOWED A MITROFLOW VALVE WITH ELEVATED GRADIENTS. THE EF IS 55-60%. THE AORTIC VALVE IS WELL SEATED, WITH NO ROCKING MOTION AND NO PARAVALVULAR LEAKS. THE LEAFLETS APPEARED THINK AND FLEXIBLE. THE MEAN/PEAK GRADIENTS WERE 33/56MMHG. THE ECHO PERFORMED IN DEC 2016 REVEALED A LVEF OF 60-65%. THE MITROFLOW VALVE APPEARED WITH ELEVATED GRADIENTS (AV MEAN GRADIENT IS 37MMHG). THE PROSTHETIC VALVE LEAFLETS APPEARED THICKENED AND CALCIFIED. THERE IS POSSIBLE PROSTHETIC STENOSIS. THE ECHO PERFORMED IN (B)(6) 2017 CONFIRMED THE PRESENCE OF ELEVATED GRADIENTS IN THE AORTI

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue

  MAUDE report 13385819 ↗
• InjuryJan 28, 2022Calcified; Calcified

  ON (B)(6) 2012, A PATIENT RECEIVED A MITROFLOW VALVE SIZE 19 AS PART OF AN AORTIC VALVE REPLACEMENT PROCEDURE. THE PATIENT¿S PREOPERATIVE DIAGNOSIS WAS OF NATIVE AORTIC VALVE STENOSIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITIONS. THE ECHO PERFORMED IN (B)(6) 2012 SHOWED A MITROFLOW VALVE ADEQUATELY FUNCTIONING (MEAN/PEAK GRADIENTS 26/45MMHG, TRACE OF AORTIC VALVE REGURGITATION). MILD MITRAL REGURGITATION IS NOTED, WITH MILD-MODERATE MITRAL ANNULAR REGURGITATION. THE LEFT VENTRICULAR WALL THICKNESS IS MILDLY INCREASED (EF IS 55-60%). THE ECHO PERFORMED IN (B)(6) 2014 SHOWED A MITROFLOW VALVE WITH ELEVATED GRADIENTS. THE EF IS 55-60%. THE AORTIC VALVE IS WELL SEATED, WITH NO ROCKING MOTION AND NO PARAVALVULAR LEAKS. THE LEAFLETS APPEARED THINK AND FLEXIBLE. THE MEAN/PEAK GRADIENTS WERE 33/56MMHG. THE ECHO PERFORMED IN (B)(6) 2016 REVEALED A LVEF OF 60-65%. THE MITROFLOW VALVE APPEARED WITH ELEVATED GRADIENTS (AV MEAN GRADIENT IS 37MMHG). THE PROSTHETIC VALVE LEAFLETS APPEARED THICKENED AND CALCIFIED. THERE IS POSSIBLE PROSTHETIC STENOSIS. THE ECHO PERFORMED IN (B)(6) 2017 CONFIRMED THE PRESENCE OF ELEVATED GRADIENTS IN THE AO

  Patient problems: Aortic Valve Stenosis; Dyspnea; Fatigue

  MAUDE report 13385805 ↗
• InjuryJan 11, 2022Calcified; Calcified

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING. THE MITROFLOW DLA21 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2017 AND EXPLANTED DUE TO STENOSIS ON (B)(6) 2021 . ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS A HISTORY OF COPD, HISTORY OF TOBACCO ABUSE, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, OBESITY, CHRONIC DIASTOLIC DISEASE. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT, MITRAL VALVE REPLACEMENT, 4 VESSEL BYPASS, MAZE PROCEDURE IN (B)(6) 2017. BASED ON THE OPERATIONAL REPORT PROVIDED, EVALUATION AND THE ECHOCARDIOGRAPHY OF THE PATIENT DEMONSTRATED AORTIC INSUFFICIENCY, AS WELL AS SOME DEGREE OF AORTIC STENOSIS. THE MITRAL VALVE ALSO HAD MILD STENOSIS AND THE MITRAL PROSTHESIS WAS OBSTRUCTING THE LEFT VENTRICULAR OUTFLOW TRACT. THUS, THE PATIENT PRESENTED FOR THE SURGICAL CORRECTION. THE PATIENT WAS STABLE DURING THE PROCEDURE AND THE OPERATION WAS PERFORMED WITHOUT ANY COMPLICATIONS. PATIENT DISCHARGED 10 DAYS POST-OP WITH STABLE CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 13232080 ↗
• InjuryJan 11, 2022Calcified; Calcified

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING. THE MITROFLOW DLA21 VALVE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2017 AND EXPLANTED DUE TO STENOSIS ON (B)(6) 2021 . ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS A HISTORY OF COPD, HISTORY OF TOBACCO ABUSE, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, OBESITY, CHRONIC DIASTOLIC DISEASE. THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT, MITRAL VALVE REPLACEMENT, 4 VESSEL BYPASS, MAZE PROCEDURE IN (B)(6) OF 2017. BASED ON THE OPERATIONAL REPORT PROVIDED, EVALUATION AND THE ECHOCARDIOGRAPHY OF THE PATIENT DEMONSTRATED AORTIC INSUFFICIENCY, AS WELL AS SOME DEGREE OF AORTIC STENOSIS. THE MITRAL VALVE ALSO HAD MILD STENOSIS AND THE MITRAL PROSTHESIS WAS OBSTRUCTING THE LEFT VENTRICULAR OUTFLOW TRACT. THUS, THE PATIENT PRESENTED FOR THE SURGICAL CORRECTION. THE PATIENT WAS STABLE DURING THE PROCEDURE AND THE OPERATION WAS PERFORMED WITHOUT ANY COMPLICATIONS. PATIENT DISCHARGED 10 DAYS POST-OP WITH STABLE CONDITION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 13231941 ↗
• InjurySep 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2014, A MITROFLOW VALVE DLA19 WAS IMPLANTED IN AORTIC POSITION. IN 2014 THE PATIENT HAD AORTIC VALVE FAILURE, CALCIFICATION AND SEVERE FATIGUE. AS REPORTED, THE PATIENT HAS BEEN IN HEART FAILURE 2 YEARS POST OP, AND WAS TAKEN TO HOSPITAL ON (B)(6) 2021 WITH TROUBLE BREATHING WHILE SEATED. THE VALVE WAS NOT EXPLANTED AS THERE WAS A VERY HIGH MORTALITY RATE. BASED ON THE ECHOCARDIOGRAM REPORTS PROVIDED ON (B)(6) 2016 AN ECHO SHOWED MODERATE ECCENTRIC AOR (PARAVALVULAR), THE PEAK GRADIENT WAS 60MMHG THE MEAN GRADIENT WAS 33MMHG. IT ALSO SHOWED SEVERE AORTIC BIOPROSTHESIS DYSFUNCTION WITH MODERATE PARAVALVULAR LEAK AND AT LEAST MODERATE AORTIC STENOSIS. IT WAS ALSO NOTED THAT THE PATIENT HAD MODERATE CENTRAL MR AND MODERATE PULMONARY HYPERTENSION WITH MODERATE TO SEVERE TRICUSPID REGURGITATION (TR). BASED ON THIS ECHO THERE WAS SIGNIFICANT WORSENING SINCE THE PREVIOUS STUDY. ON (B)(6) 2019 THE ECHO SHOWED EVIDENCE OF SEVERE STENOSIS OF THE AORTIC VALVE PROSTHESIS, MILD PARAVALVULAR AORTIC REGURGITATION, MEAN GRADIENT IS 31MMHG. IT WAS ALSO NOTED THAT THE PATIENT HAD MITRAL ANNULAR CALCIFICATION AND MODERATE MITRAL REGURGITATION. ON (B)(6) 2021 THE ECHO SHOWED THAT THE RCC IS

  Patient problems: Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 12438750 ↗
• InjurySep 7, 2021Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2014, A PATIENT WITH AORTIC VALVE FAILURE, CALCIFICATION AND FATIGUE UNDERWENT TO AORTIC VALVE REPLACEMENT. A MITROFLOW VALVE DLA19 (SIZE 19) WAS IMPLANTED. ON (B)(6) 2016, AN ECHO REPORTED MODERATE ECCENTRIC PARAVALVULAR LEAK, WITH PEAK GRADIENT OF 66 MMHG AND MEAN GRADIENT 33 MMHG. SEVERE AORTIC DYSFUNCTION WITH MODERATE REGURGITATION AND STENOSIS. MODERATE CENTRAL MITRAL REGURGITATION (MR), MODERATE PULMONARY HYPERTENSION, RV SIZE AND FUNCTION PRESERVED. RV PACEMAKER LEAD IN PLACE. MILD PULMONARY INSUFFICIENCY (IT IS REPORTED SIGNIFICANT WORSENING SINCE PREVIOUS STUDY). ON (B)(6) 2019 THE ECHO SHOWED EVIDENCE OF SEVERE STENOSIS OF THE AORTIC VALVE PROSTHESIS, MILD PARAVALVULAR AORTIC REGURGITATION, MEAN GRADIENT IS 31MMHG. IT WAS ALSO NOTED THAT THE PATIENT HAD MITRAL ANNULAR CALCIFICATION AND MODERATE MITRAL REGURGITATION. LEFT ATRIUM VOLUME IS MODERATELY INCREASED (IT IS REPORTED THAT; COMPARED WITH PREVIOUS, THE STUDY IS SIMILAR, HOWEVER WITH RIGHT VENTRICULAR SYSTOLIC PRESSURE IS LOWER). ON (B)(6) 2021 TEE WAS COMPLETED TO VERIFY POSSIBILITY FOR VIV; THE ECHO SHOWED THAT THE RCC IS IMMOBILE, GRADIENTS ARE ELEVATED ACROSS THE VALVE, MILD CENTRAL AI AND MODERATE PARA

  Patient problems: Aortic Valve Stenosis; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 12437009 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW LXA25 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12425047 ↗
• Sep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW LXA23 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12425042 ↗

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