MITROFLOW LXA23Recalls & reported problems
Corcym Canada Corp · Class 3 · Implant
Quick summary
This MitroFlow LXA23 is a tissue-based heart valve that is surgically implanted to replace a damaged aortic valve. The 34 reports mostly describe the valve tissue becoming thickened, hardened or calcified over time, with some cases where the valve opening narrowed enough to stop working properly. Reports mention 1 death and 32 injuries. No recalls name this device, and no reports were filed in the past 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 1
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00896208000115), received between Jun 16, 2016 and Jun 23, 2022 — classified as 1 death, 32 injuries.
The most frequently reported specific device problem is “Degraded” (24 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
- Degraded24
- Insufficient Device Problem Information6
- Gradient Increase4
- Calcified3
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
- Material Too Rigid or Stiff1
Patient problems
- Insufficient Information19
- No Information7
- Aortic Valve Stenosis4
- Cardiogenic Shock3
- Aortic Insufficiency2
- Heart Failure2
- Pulmonary Insufficiency2
- Pulmonary Regurgitation2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 12424946 ↗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 12423968 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW LXA27 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12422801 ↗InjurySep 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 12422777 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 19TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12422708 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 18TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12422672 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 17TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12422655 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW LXA27 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12422319 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 5TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12421863 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 4TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12421810 ↗InjurySep 3, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTICALCIFICATION METHOD. THIS CASE REFERS TO THE 2ND SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12421680 ↗InjurySep 2, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 19TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12417459 ↗InjurySep 2, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE MODEL LXA23 WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12417376 ↗InjurySep 2, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 17TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12417224 ↗InjurySep 2, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 7TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12416343 ↗InjurySep 2, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 5TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12416197 ↗InjurySep 1, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE WAS REPORTED. THE SURGEON PROVIDED 31 SERIAL NUMBERS, AND WAS INQUIRING ABOUT WHICH MODEL (DLA OR LXA) EACH VALVE WAS, AND ALSO WHICH VALVE HAS THE OLD OR THE NEW ANTI-CALCIFICATION METHOD. THIS CASE REFERS TO THE 4TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12411677 ↗InjuryAug 31, 2021Degraded; Degraded
ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW VALVE MODEL LXA23 WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12401625 ↗InjuryOct 30, 2020Degraded; Degraded
THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A MITROFLOW LXA23 THAT WAS IMPLANTED ON (B)(6) 2012 WAS EXPLANTED ON (B)(6) 2020. BASED ON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE PATIENT DID WELL UP UNTIL (B)(6) 2020, WHEN THE PATIENT PRESENTED TO THE EMERGENCY ROOM IN FLORID PULMONARY EDEMA, CARDIOGENIC SHOCK. ECHOCARDIOGRAPHY CONFIRMED SEVERE AORTIC VALVE INSUFFICIENCY WITH PROBABLY EITHER A TORN LEAFLET OR DISRUPTION, NO SIGNS FOR ENDOCARDITIS. THE PATIENT RECEIVED AN IMPELLA TO RELIEVE THE VOLUME LOAD AND OVER THE COURSE OF THE NEXT 48 HOURS THE PATIENT'S CONDITION STABILIZED NICELY. A VALVE REPLACEMENT WAS THEN PERFORMED. UPON INSPECTION, THE AORTIC VALVE DID HAVE SOME FLIMSY MATERIAL ON IT, ALTHOUGH IT DID NOT APPEAR AT ALL INFECTED. THE RIGHT CORONARY LEAFLET WAS FIBROTIC AND RIGID, AND THIS WAS REPORTEDLY THE CAUSE OF THE LEAK. A DECISION WAS MADE TO IMPLANT A MECHANICAL VALVE THIS TIME AND A CARBOMEDICS S5-021 WAS ULTIMATELY IMPLANTED. THE PATIENT WAS TRANSFERRED BACK TO THE ICU IN STABLE CONDITIONS AND RECOVERED WELL POSTOPERATIVELY. THE PATIENT WAS RESTART
Patient problems: Aortic Insufficiency; Cardiogenic Shock; Heart Failure; Respiratory Failure
MAUDE report 10766989 ↗InjuryOct 30, 2020Degraded; Degraded
THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A MITROFLOW LXA23 THAT WAS IMPLANTED ON (B)(6) 2012 WAS EXPLANTED ON (B)(6) 2020. BASED ON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE PATIENT DID WELL UP UNTIL (B)(6) 2020, WHEN THE PATIENT PRESENTED TO THE EMERGENCY ROOM IN FLORID PULMONARY EDEMA, CARDIOGENIC SHOCK. ECHOCARDIOGRAPHY CONFIRMED SEVERE AORTIC VALVE INSUFFICIENCY WITH PROBABLY EITHER A TORN LEAFLET OR DISRUPTION, NO SIGNS FOR ENDOCARDITIS. THE PATIENT RECEIVED AN IMPELLA TO RELIEVE THE VOLUME LOAD AND OVER THE COURSE OF THE NEXT 48 HOURS THE PATIENT'S CONDITION STABILIZED NICELY. A VALVE REPLACEMENT WAS THEN PERFORMED. UPON INSPECTION, THE AORTIC VALVE DID HAVE SOME FLIMSY MATERIAL ON IT, ALTHOUGH IT DID NOT APPEAR AT ALL INFECTED. THE RIGHT CORONARY LEAFLET WAS FIBROTIC AND RIGID, AND THIS WAS REPORTEDLY THE CAUSE OF THE LEAK. A DECISION WAS MADE TO IMPLANT A MECHANICAL VALVE THIS TIME, AND A CARBOMEDICS S5-021 WAS ULTIMATELY IMPLANTED. THE PATIENT WAS TRANSFERRED BACK TO THE ICU IN STABLE CONDITIONS AND RECOVERED WELL POSTOPERATIVELY. THE PATIENT WAS RESTAR
Patient problems: Aortic Insufficiency; Cardiogenic Shock; Heart Failure; Respiratory Failure
MAUDE report 10766966 ↗InjuryJul 28, 2019Degraded; Gradient Increase; Degraded; Gradient Increase
A PATIENT WAS IMPLANTED WITH A MITROFLOW LXA SIZE 23 (SN (B)(4)) ON (B)(6) 2013. AT THE TIME OF IMPLANT THE PATIENT WAS 35 YEARS OLD. ON (B)(6) 2016 THE PATIENT UNDERWENT TO A RE-OPERATION FOR THE REPLACEMENT OF THE BIOPROSTHESIS DUE TO DEGRADATION AT THE (B)(6) HOSPITAL. BASED ON THE INFORMATION AVAILABLE THE PATIENT HAD PULMONARY STENOSIS IN THE MITROFLOW VALVE (45-50 MMHG) WITH PULMONARY REGURGITATION, RIGHT CHAMBER ENLARGEMENT AND DECREASED RIGHT VENTRICLE MOBILITY.
Patient problems: Pulmonary Insufficiency; Pulmonary Regurgitation; Pulmonary Valve Stenosis
MAUDE report 8834814 ↗InjuryJul 28, 2019Gradient Increase; Gradient Increase
A PATIENT WAS IMPLANTED WITH A MITROFLOW LXA SIZE 23 (SN (B)(4)) ON (B)(6) 2013. AT THE TIME OF IMPLANT THE PATIENT WAS (B)(6) YEARS OLD. ON (B)(6) 2016 THE PATIENT UNDERWENT TO A RE-OPERATION FOR THE REPLACEMENT OF THE BIOPROSTHESIS DUE TO DEGRADATION AT THE (B)(6) HOSPITAL. BASED ON THE INFORMATION AVAILABLE, THE PATIENT HAD PULMONARY STENOSIS IN THE MITROFLOW VALVE (45-50 MMHG) WITH PULMONARY REGURGITATION, RIGHT CHAMBER ENLARGEMENT AND DECREASED RIGHT VENTRICLE MOBILITY.
Patient problems: Pulmonary Insufficiency; Pulmonary Regurgitation; Pulmonary Valve Stenosis
MAUDE report 8834805 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.