MITROFLOW DLA25Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00896208000184), received between Dec 21, 2016 and Sep 3, 2021 — classified as 2 deaths, 19 injuries.

The most frequently reported specific device problem is “Degraded” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW DLA25 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12423785 ↗
• InjurySep 3, 2021Degraded; Degraded

  ON (B)(6) 2021, AN EVENT OF SVD ON A MITROFLOW DLA25 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422803 ↗
• 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 20TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422741 ↗
• 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 9TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422214 ↗
• 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 20TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12417569 ↗
• InjurySep 2, 2021Degraded; Degraded

  ON 5 AUG 2021, AN EVENT OF SVD ON A MITROFLOW VALVE MODEL DLA25 WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12416461 ↗
• InjuryApr 24, 2020Degraded; Degraded

  ON (B)(6) 2013, A PATIENT RECEIVED A MITROFLOW DLA25 IN AORTIC POSITION. ON (B)(6) 2020, THE PATIENT EXPERIENCED VISUAL AMAUROSIS, OCCLUSION OF THE CENTRAL RETINAL ARTERY AND TRANSIENT ISCHEMIC ATTACK (ISCHEMIC ETIOLOGY). THE PATIENT IS REPORTEDLY UNDER A WELL-CONDUCTED ANTICOAGULATION THERAPY (PREVISCAN, INR 2.7). A TRANSTHORACIC ECHOCARDIOGRAPHY WAS PERFORMED ON (B)(6) 2020, WHICH REVEALED THE PRESENCE OF TEARS IN THE PERICARDIUM OF THE DEVICE (3-4MM NEXT TO THE NON-CORONARY SINUS AND 11M IN THE VALSALVA SINUS). ON (B)(6) 2020, THE PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT, AND THE DLA25 VALVE WAS EXPLANTED.

  Patient problems: Embolism; Stroke/CVA; Visual Disturbances

  MAUDE report 9996635 ↗
• InjuryApr 24, 2020Degraded; Degraded

  ON (B)(6) 2013, A PATIENT RECEIVED A MITROFLOW DLA25 IN AORTIC POSITION. ON (B)(6) 2020, THE PATIENT EXPERIENCED VISUAL AMAUROSIS, OCCLUSION OF THE CENTRAL RETINAL ARTERY AND TRANSIENT ISCHEMIC ATTACK (ISCHEMIC ETIOLOGY). THE PATIENT IS REPORTEDLY UNDER A WELL-CONDUCTED ANTICOAGULATION THERAPY (PREVISCAN, INR 2.7). A TRANSTHORACIC ECHOCARDIOGRAPHY WAS PERFORMED ON (B)(6) 2020, WHICH REVEALED THE PRESENCE OF TEARS IN THE PERICARDIUM OF THE DEVICE (3-4MM NEXT TO THE NON-CORONARY SINUS AND 11M IN THE VALSALVA SINUS). ON (B)(6) 2020, THE PATIENT UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT, AND THE DLA25 VALVE WAS EXPLANTED.

  Patient problems: Embolism; Stroke/CVA; Visual Disturbances

  MAUDE report 9996581 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015 A PATIENT RECEIVED A CROWN PRT CNA25 AORTIC HEART VALVE IMPLANT AS PART OF THE SURE-AVR TRIAL VIA MEDIAN STERNOTOMY. A CONCOMITANT CABG WAS PERFORMED. THE MANUFACTURE WAS NOTIFIED OF A SERIOUS ADVERSE EVENT. ON (B)(6) 2015 THE PATIENT DIED FROM CARDIOVASCULAR MORTALITY / ALL VALVE-RELATED DEATHS / ENDOCARDITIS.

  Patient problems: Endocarditis

  MAUDE report 8113674 ↗
• DeathAug 1, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A MITROFLOW DLA25 WAS IMPLANTED ON (B)(6) 2018. AT DISCHARGE THE PATIENT HAD A MEAN GRADIENT OF 7.0 MMHG, AND WAS IN NYHA CLASS II. ON (B)(6) 2016, THE PATIENT'S MEAN AORTIC GRADIENT WAS 16 MMHG, AND THE PATIENT WAS IN NYHA CLASS III. THE PATIENT DIED ON (B)(6) 2016, DUE TO AN APPARENTLY NON-DEVICE RELATED EVENT.

  Patient problems: Endocarditis; Stroke/CVA

  MAUDE report 7741256 ↗
• InjuryJul 24, 2018Material Deformation; Material Deformation

  A MITROFLOW DLA WAS IMPLANTED ON (B)(6) 2015. AT DISCHARGE THE PATIENT'S MEAN GRADIENT WAS REPORTED TO BE 9 MMHG WITH NO CENTRAL OR PARAVALVULAR LEAK. AT ONE-YEAR FOLLOW-UP ON (B)(6) 2016, THE MEAN GRADIENT WAS 30 MMHG, AND AT TWO-YEAR FOLLOW UP ON (B)(6) 2017, THE MEAN GRADIENT WAS 25 MMHG, WITH NO CENTRAL OR PARAVALVULAR LEAK. ON (B)(6) 2017 THE VALVE WAS EXPLANTED DUE TO STRUCTURAL VALVE DETERIORATION. THE VALVE WAS REPORTEDLY CALCIFIED. THE PATIENT WAS REPORTED TO HAVE A SYSTOLIC PULMONARY ARTERIAL PRESSURE WAS <50 MMHG PRIOR TO VALE IMPLANT. PATIENT HAD PRE-OPERATIVE DYSLIPIDEMIA. THE PATIENT WAS NOT AT RISK FOR PATIENT PROSTHESIS MISMATCH. THE VALVE WAS REPORTEDLY EXPLANTED AT AN OUTLYING HOSPITAL. RECORDS OF THE EXPLANT WERE REQUESTED BY THE IMPLANTING SITE, BUT NOT RECEIVED AT THE TIME OF REPORTING.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7714776 ↗
• DeathMay 15, 2018Perivalvular Leak; Adverse Event Without Identified Device or Use Problem; Perivalvular Leak; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING SERIES OF EVENTS VIA THE SURE AVR PATIENT REGISTRY. A MITROFLOW DLA SIZE 25 WAS IMPLANTED ON (B)(6) 2013. ON (B)(6) 2016, THE PATIENT EXPERIENCED CARDIAC DECOMPENSATION. ON (B)(6) 2016 THE PATIENT EXPERIENCED CHEST TRAUMA WITH RIB FRACTURES AND HEMOTHORAX, AND ON (B)(6) 2017 THE PATIENT PASSED AWAY DUE TO WORSENING HEART FAILURE. THE PATIENT HAD A HISTORY OF ISCHEMIC STROKE ((B)(6) 2014) AND ENDOCARDITIS ((B)(6) 2015). ACCORDING TO THE INFORMATION IN THE REGISTRY, AT A FOLLOW UP VISIT ON (B)(6) 2015, THE VALVE WAS FUNCTIONING WELL. ON (B)(6) 2016, PARAVALVULAR LEAK (2+) AND CENTRAL LEAK (2+) WITH SVD WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Regurgitation; Bone Fracture(s); Endocarditis; Heart Failure; Hemothorax; Stroke/CVA

  MAUDE report 7515856 ↗
• InjuryMay 7, 2018Gradient Increase; Gradient Increase

  ON (B)(6) 2016 A MITROFLOW DLA25 WAS IMPLANTED AS PART OF THE MITROFLOW-PAS STUDY. ON (B)(6) 2018 THE MANUFACTURER WAS NOTIFIED OF TWO SERIOUS ADVERSE EVENTS VIA THE MITROFLOW-PAS CLINICAL REGISTRY. THE PATIENT WAS REPORTED TO HAVE CONGESTIVE HEART FAILURE ON (B)(6) 2018 AND HEART FAILURE ON (B)(6) 2018. UPON FURTHER REVIEW OF THE PATIENT HISTORY IT WAS RECORDED THAT THE PATIENT SUFFERED AN ISCHEMIC STROKE (B)(6) 2017. THIS IS A NON-DEVICE RELATED ISSUE.

  Patient problems: Congestive Heart Failure; Heart Failure

  MAUDE report 7493057 ↗
• InjuryMar 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2017 A MITROFLOW DLA25 WAS IMPLANTED. THE SURGEON DECIDED HE DID NOT LIKE THE FIT OF THE VALVE AND IT WAS AN INCORRECT SIZE FOR THE PATIENT. THEY REMOVED IT IMMEDIATELY AND REPLACED IT WITH ANOTHER SIZE OF VALVE. THE PATIENT OUTCOME IS FINE. ADDED X-CLAMP TIME WAS NOT SPECIFIED.

  Patient problems: No Information

  MAUDE report 7311849 ↗
• InjuryFeb 13, 2018Calcified; Calcified

  MANUFACTURER WAS NOTIFIED THAT PATIENT WHO HAD MITROFLOW DLA VALVE IMPLANTED ON (B)(6) 2016 UNDERWENT AORTIC VALVE REPLACEMENT ON (B)(6) 2018 AND THE DEVICE WAS REPLACED WITH MECHANICAL VALVE.

  Patient problems: Aortic Valve Stenosis; Corneal Pannus; Thrombus

  MAUDE report 7268657 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON OCT 19, 2017 THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF THE FOLLOWING EVENT. ON (B)(6) 2017 A MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL DL WAS EXPLANTED DUE TO SEVERE REGURGITATION, FROM A PATIENT UNDER 55 YEARS, THE DEVICE HAD PREVIOUSLY BEEN IMPLANTED ON (B)(6) 2014. A CARBOMEDICS REDUCED AORTIC VALVE R5-025 WAS THEN IMPLANTED.

  Patient problems: Aortic Regurgitation

  MAUDE report 7041369 ↗
• InjuryOct 24, 2017Material Too Rigid or Stiff; Material Deformation; Material Too Rigid or Stiff; Material Deformation

  A MITROFLOW DLA25 WAS IMPLANTED IN A (B)(6) YEAR OLD MALE ON (B)(6) 2014. A RECENT CARDIOLOGY REPORT STATES THAT VALVE IS SHOWING SIGNS OF EARLY SVD. THE PATIENT IS BEING MONITORED AND WILL HAVE ADDITIONAL IN-HOSPITAL TESTS CONDUCTED IN A FEW WEEKS.

  Patient problems: No Information

  MAUDE report 6974681 ↗
• InjuryOct 24, 2017Material Too Rigid or Stiff; Adverse Event Without Identified Device or Use Problem; Material Too Rigid or Stiff; Adverse Event Without Identified Device or Use Problem

  A MITROFLOW DLA25 WAS IMPLANTED IN A (B)(6) MALE WITH A NATIVE BICUSPID VALVE ON (B)(6) 2015. THE PATIENT IS VERY FIT. A RECENT CARDIOLOGY REPORT STATES THAT THE VALVE LEAFLETS ARE NOT FUNCTIONING PROPERLY DUE TO AORTIC STENOSIS. THE PATIENT IS BEING MONITORED AND WILL HAVE ADDITIONAL IN-HOSPITAL TESTS CONDUCTED IN A FEW WEEKS BEFORE EXPLANTING THE VALVE. ADDITIONAL INFORMATION RECEIVED ON OCT 24, 2017 INDICATED THAT THE PATIENT HAD ANOTHER ECHO DONE AND THE VALVE FUNCTION WAS DEEMED TOTALLY NORMAL. NO FURTHER ACTION WILL BE TAKEN.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 6974511 ↗
• InjuryJul 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JUNE 12TH 2017 THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF A MITROFLOW DLA SIZE 25 VALVE THAT WAS IMPLANTED ON (B)(6) 2014 AND EXPLANTED ON (B)(6) 2017. AFTER 2.7 YEARS IMPLANT DURATION. A CARBOSEAL VALSALVA ASCENDING AORTIC PROSTHESIS CP-023 WAS IMPLANTED. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Information

  MAUDE report 6699722 ↗
• InjuryFeb 2, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THAT A MITROFLOW DLA27 WAS IMPLANTED ON (B)(6) 2014 AND EXPLANTED (B)(6) 2016 DUE TO ENDOCARDITIS. UPON EXPLANT, THE VALVE REPORTEDLY "LOOKED FINE, BESIDES A LITTLE BIT OF VEGETATION GROWING ON THE SIDE." BECAUSE IT WAS NOT A STRUCTURAL DETERIORATION PROBLEM, THEY REPORTEDLY IMPLANTED ANOTHER BIOCONDUIT SUCCESSFULLY. THE VALVE WAS REPLACED WITH A MITROFLOW DLA25, AND THE BIOCONDUIT IMPLANTED WAS A MITROFLOW VALSALVA OF CORRESPONDING SIZE.

  Patient problems: Endocarditis; No Information

  MAUDE report 6298654 ↗
• InjuryDec 21, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  FOLLOW-UP SHOWED THAT IT WAS LIKELY THAT IN (B)(6) THE PATIENT HAD COME BACK FOR A MITRAL VALVE THAT HE DIDN¿T FIX DURING THE FIRST SURGERY IN (B)(6) AND THAT THE AORTIC VALVE WAS LIKELY REPLACED FROM OVERSIZING THAT LED TO THE MITRAL VALVE WORSENING. NO OTHER ADDITIONAL DETAILS WERE PROVIDED FROM THE SURGEON¿S OFFICE.

  Patient problems: No Information

  MAUDE report 6197209 ↗