MITROFLOW LXA21Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00896208000108), received between Jun 16, 2016 and May 1, 2024 — classified as 5 deaths, 22 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 27 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW LXA21 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12423808 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW LXA21 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422492 ↗
• 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 3RD SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12421768 ↗
• 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 3RD SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12411680 ↗
• InjuryAug 21, 2019Calcified; Degraded; Insufficient Device Problem Information; Calcified; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2014 A PATIENT RECEIVED A MITROFLOW LXA21 AORTIC HEART VALVE. THE MANUFACTURER WAS NOTIFIED THE SURGEON EXPLANTED THE AORTIC VALVE AFTER +/- 4.6 YEARS, ON (B)(6) 2019. PATIENT (MALE) WAS +/- 70 YEARS OF AGE WHEN HE RECEIVED THE FIRST IMPLANT. VALVE WAS REPLACED WITH A EDWARDS PERIMOUNT 23MM.

  Patient problems: No Information

  MAUDE report 8919130 ↗
• InjuryAug 21, 2019Calcified; Degraded; Insufficient Device Problem Information; Calcified; Degraded; Insufficient Device Problem Information

  ON (B)(6) 2014 A PATIENT RECEIVED A MITROFLOW LXA21 AORTIC HEART VALVE. THE MANUFACTURER WAS NOTIFIED THE SURGEON EXPLANTED THE AORTIC VALVE AFTER +/- 4.6 YEARS, ON JUL. 25, 2019. PATIENT (MALE) WAS +/- 70 YEARS OF AGE WHEN HE RECEIVED THE FIRST IMPLANT. VALVE WAS REPLACED WITH A EDWARDS PERIMOUNT 23MM. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ON OCT. 23, 2019 IDENTIFYING THE PATIENT OUTCOME WAS FINE.

  Patient problems: No Information

  MAUDE report 8919124 ↗
• InjuryJun 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A MITROFLOW LXA21 WAS IMPLANTED ON (B)(6) 2013. THE VALVE WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A PERCEVAL PVS23. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Information

  MAUDE report 8693417 ↗
• InjuryMay 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A MITROFLOW LXA21 WAS IMPLANTED ON (B)(6), 2015. ON (B)(6) 2019, THE VALVE WAS EXPLANTED AND REPLACED WITH A CROWN CNA21. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 8647832 ↗
• DeathFeb 20, 2019Gradient Increase; Gradient Increase

  A MITROFLOW LXA21 WAS IMPLANTED ON (B)(6) 2013 DUE TO SEVERE AORTIC STENOSIS. IN 2019 A VALVE-IN-VALVE WAS SCHEDULED DUE TO WORSENING DYSPNEA ON EXERTION AND FATIGUE DURING ACTIVITIES. THE PATIENT WAS IN NYHA CLASS III AT FOLLOW-UP IN 2019, WITH A PEAK GRADIENT OF 68 MMHG AND AN AORTIC VALVE AREA OF 0.68 CM2. THE PATIENT HAD DIFFUSE CORONARY DISEASE AND A HISTORY OF HYPERLIPIDEMIA AND HYPERTENSION. REINTERVENTION WAS PERFORMED ON (B)(6) 2019. THE PATIENT PASSED AWAY POST-OPERATIVELY ON (B)(6) 2019.

  Patient problems: Aortic Valve Stenosis; Death; Dyspnea

  MAUDE report 8356320 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT IS RELATED TO A MITROFLOW VALVE LXA21 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A MITROFLOW DLA19 ON (B)(6)2014. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Information

  MAUDE report 8318823 ↗
• InjuryNov 21, 2018Material Deformation; Material Deformation

  RECEIVED INFORMATION FROM SURE AVR REGISTRY ABOUT SUBJECT: (B)(4), A (B)(6) -YEAR OLD, FEMALE PATIENT. ON (B)(6) 2011, A MITROFLOW LXA21 WAS IMPLANTED VIA MEDIAN STERNOTOMY. NO CONCOMITANT PROCEDURE WAS PERFORMED. THE SITE INDICATED AE 1 - VALVE RELATED SERIOUS ADVERSE EVENT: NON-STRUCTURAL DYSFUNCTION / OTHER NON STRUCTURAL DYSFUNCTION: EARLY DEGENERATION OF THE AORTIC VALVE PROSTHESIS. MIXED VALVULOPATHY COMPLICATED BY SYSTOLIC-DIASTOLIC LEFT VENTRICULAR FAILURE, THAT OCCURRED ON (B)(6) 2015. THE SITE INDICATED AE 3 - REINTERVENTION / OTHER: DEGENERATION OF THE VALVE / TRANSCATHETER VALVE REPLACEMENT, THAT OCCURRED ON (B)(6) 2016. UPON REVIEW OF THE SURE-AVR DATABASE A SECOND SAE OCCURRED. SAE 2 - CANCER: ADENOCARCINOMA OF THE CARDIA, WHICH OCCURRED ON (B)(6) 2017. THIS EVENT WAS DEEMED NOT DEVICE RELATED BY THE SITE.

  Patient problems: Aortic Insufficiency

  MAUDE report 8097936 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 A MITROFLOW LXA21 WAS IMPLANTED. ON (B)(6) 2018 THE DEVICE WAS EXPLANTED AND REPLACED WITH A CROWN CNA23 AORTIC HEART VALVE IMPLANT. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 7705313 ↗
• InjuryMar 7, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A MITROFLOW VALVE WAS EXPLANTED AFTER 4.5 YEARS WITH SIGNIFICANT STRUCTURAL VALVE DETERIORATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7320750 ↗
• DeathOct 11, 2017Gradient Increase; Material Deformation; Gradient Increase; Material Deformation

  ON (B)(6) 2017 THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING: MITROFLOW LXA 21 ¿THAT WAS PREVIOUSLY IMPLANTED ON (B)(6) 2014, WAS EXPLANTED ON (B)(6) 2017 DUE TO EARLY DEGENERATION (3.49 YRS IMPLANT DURATION). PRIOR TO EXPLANT THE PATIENT PRESENTED WITH SHORTNESS OF BREATH ON EXERTION AND REST PRIOR TO EXPLANT. VALVE GRADIENT GREATER THAN 100MMHG PRE OP. ONE LEAFLET CALCIFIED AND NOT MOVING, VALVE WAS EXTREMELY CALCIFIED. THE PATIENT WAS STRUGGLING PRIOR TO SURGERY. A BALLOON PUMP WAS PLACED PRE-OPERATIVELY AND THE PATIENT STABILIZED. RE-OPERATION WAS PERFORMED AND THE MITROFLOW VALVE WAS EXPLANTED, DURING THE PROCEDURE THEY TRIED TO UTILIZE A ST JUDE MECHANICAL SIZER BUT THE AORTA AFTER EXPLANT WAS VERY TIGHT SO THE BIGGEST SIZER THEY COULD FIT WAS A 17MM, THEY THEN USED A TOP HAT SIZER AND THE BIGGEST SIZE WAS A 19MM SO THIS WAS IMPLANTED. THE PATIENT CAME OFF BYPASS WITH MINIMAL DRUG SUPPORT AND THE BALLOON PUMP, PRESSURES AND OUTPUT WERE NORMAL, THE POST OP TEE SHOWED SOME TURBULENCE OF FLOW FROM THE NEWLY IMPLANTED TOP HAT VALVE BASED ON THE FACT THERE WAS SOME PPM (WITH TOP HAT), MEAN GRADIENT WAS IN THE 28-32MMHG RANGE. CHEST WAS CLOSED AND THEN IT WAS NOTICED THERE WAS NO

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; Death; Dyspnea; Thrombus

  MAUDE report 6940098 ↗
• InjurySep 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS WAS A BICUSPID VALVE AND THE SURGEON WANTED TO TRY AND MAKE A PERCEVAL VALVE WORK. THE DEVICE WAS IMPLANTED, HOWEVER THE PATIENT WAS BETTER SUITED FOR A STENTED VALVE SO THE DEVICE WAS EXPLANTED AND REPLACED WITH AN EW MAGNA VALVE. THERE WAS ABOUT 25 MIN ADDED TO THE CASE. THE PATIENT IS DOING FINE. THE EVENT OCCURRED ON (B)(6) 2017, AND THE MANUFACTURER WAS NOTIFIED ON 31-AUG-2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6902887 ↗
• InjurySep 7, 2017Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  THE VALVE WAS EXPLANTED FROM THE PULMONARY POSITION DUE TO AN OBSTRUCTION(CALCIFICATION) AND REPLACED WITH A PULMONARY HOMOGRAFT. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Information

  MAUDE report 6850199 ↗
• InjuryJul 10, 2017Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  ON (B)(4) 2017 THE MANUFACTURER WAS NOTIFIED BY PATIENT TRACKING OF A MITROFLOW LXA21 THAT WAS IMPLANTED ON (B)(6) 2013 AND EXPLANTED ON (B)(6) 2017, AFTER 4.27 YEARS. A PVS21 WAS THEN IMPLANTED. NO FURTHER INFORMATION IS KNOWN AT PRESENT.

  Patient problems: No Information

  MAUDE report 6699706 ↗
• InjuryMay 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MITROFLOW LXA21 WAS EXPLANTED AFTER 4.68 YEARS AND REPLACED BY PERCEVAL PVS21.

  Patient problems: No Information

  MAUDE report 6537148 ↗
• InjuryNov 9, 2016Material Deformation; Material Deformation

  THE MANUFACTURER WAS NOTIFIED ON 11 OCT 2016 THAT A MITROFLOW VALVE WAS EXPLANTED AFTER 5 YEARS DUE TO DEGENERATION OF THE DEVICE. A PERCEVAL, PVS21 WAS IMPLANTED.

  Patient problems: No Information

  MAUDE report 6091426 ↗
• InjurySep 28, 2016Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT REGISTRATION FORM ((B)(4)) ON (B)(6) 2016 THAT A MITROFLOW VALVE LXA21 SN# (B)(4) WAS IMPLANTED ON (B)(6) 2012 WAS EXPLANTED ON (B)(6) 2016 AND ANOTHER DEVICE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Calcium Deposits/Calcification; No Information

  MAUDE report 5984986 ↗
• InjurySep 23, 2016Calcified; Material Deformation; Calcified; Material Deformation

  THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2016 THAT A MITROFLOW VALVE (LXA21, S/N (B)(4)) WAS EXPLANTED AFTER 2 YEARS DUE TO INSUFFICIENCY AND STENOSIS.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 5973462 ↗
• InjurySep 21, 2016Calcified; Calcified

  THE MANUFACTURER WAS NOTIFIED ON 25 AUG 2016 THAT A PATIENT WHO WAS IMPLANTED WITH MITROFLOW LXA, SIZE 21 ON (B)(6) 2014 SHOWED RESTRICTED LEAFLET MOVEMENT DUE TO CALCIFICATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Aortic Insufficiency; Calcium Deposits/Calcification

  MAUDE report 5968462 ↗
• InjurySep 21, 2016Calcified; Gradient Increase; Calcified; Gradient Increase

  THE MANUFACTURER WAS NOTIFIED ON 25 AUG 2016, THAT A PATIENT WHO WAS IMPLANTED WITH MITROFLOW LXA, SIZE 21 ON (B)(6) 2013 SHOWED RESTRICTED LEAFLET MOVEMENT DUE TO CALCIFICATION, AVA 1.0 CM2, PG 73MMHG. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Aortic Insufficiency; Calcium Deposits/Calcification

  MAUDE report 5968455 ↗