MITROFLOW LXA25Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00896208000122), received between Nov 23, 2016 and Sep 3, 2021 — classified as 2 deaths, 17 injuries.

The most frequently reported specific device problem is “Degraded” (12 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 19 most recent of 19 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 LXA25 VALVE WAS REPORTED. THE IMPLANT TIME AND PATIENT IMPACT ARE PRESENTLY UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12425047 ↗
• 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 12424192 ↗
• 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 21ST SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422770 ↗
• 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 ANTI CALCIFICATION METHOD. THIS CASE REFERS TO THE 15TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422565 ↗
• 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 1ST SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12421627 ↗
• 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 21ST SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12417687 ↗
• 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 1ST SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12411674 ↗
• 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 15TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12411653 ↗
• InjuryJul 20, 2021Degraded; Degraded

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A MITROFLOW VALVE MODEL LXA25 WAS IMPLANTED ON (B)(6) 2012 AND IT WAS EXPLANTED ON (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVE ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT FROM THE HOSPITAL REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, THE PREOPERATIVE DIAGNOSIS INDICATED SEVERE PROSTHETIC AORTIC INSUFFICIENCY AND AORTIC STENOSIS OF THE MITROFLOW VALVE. THE PATIENT UNDERWENT A REDO STERNOTOMY, REDO AORTIC VALVE REPLACEMENT WITH A 23 INSPIRIS PERICARDIAL VALVE. THE PROCEDURE WAS PERFORMED UNEVENTFULLY. OVER THE LAST YEAR, THE PATIENT HAD MULTIPLE REHOSPITALIZATIONS FOR HEART FAILURE AND WAS NOTED TO HAVE A DETERIORATED PROSTHETIC VALVE WITH SEVERE AORTIC INSUFFICIENCY AND AORTIC STENOSIS. THE PATIENT WAS EVALUATED FOR A TAVR AND BECAUSE OF THE LOW TAKEOFF THE CORONARY ARTERIES, THE PATIENT WAS NOT DEEMED A CANDIDATE FOR THE TAVR PROCEDURE. OTHER HISTORY IS NOTABLE FOR CHRONICALLY OCCLUDED RIGHT HEMIDIAPHRAGM AND COPD.

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

  MAUDE report 12196180 ↗
• InjuryJul 19, 2021Degraded; Degraded

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A MITROFLOW VALVE MODEL LXA25 WAS IMPLANTED ON (B)(6) 2012 AND IT WAS EXPLANTED ON (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVE ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT FROM THE HOSPITAL REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, THE PREOPERATIVE DIAGNOSIS INDICATED SEVERE PROSTHETIC AORTIC INSUFFICIENCY AND AORTIC STENOSIS OF THE MITROFLOW VALVE. THE PATIENT UNDERWENT A REDO STERNOTOMY, REDO AORTIC VALVE REPLACEMENT WITH A 23 INSPIRIS PERICARDIAL VALVE. THE PROCEDURE WAS PERFORMED UNEVENTFULLY. OVER THE LAST YEAR, THE PATIENT HAD MULTIPLE RE-HOSPITALIZATIONS FOR HEART FAILURE AND WAS NOTED TO HAVE A DETERIORATED PROSTHETIC VALVE WITH SEVERE AORTIC INSUFFICIENCY AND AORTIC STENOSIS. THE PATIENT WAS EVALUATED FOR A TAVR AND BECAUSE OF THE LOW TAKEOFF THE CORONARY ARTERIES, THE PATIENT WAS NOT DEEMED A CANDIDATE FOR THE TAVR PROCEDURE. OTHER HISTORY IS NOTABLE FOR CHRONICALLY OCCLUDED RIGHT HEMIDIAPHRAGM AND COPD.

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

  MAUDE report 12192658 ↗
• DeathMar 12, 2020Degraded; Fluid/Blood Leak; Degraded; Fluid/Blood Leak

  THE MANUFACTURER WAS MADE AWARE OF A SERIOUS ADVERSE EVENT WHICH INVOLVED A PATIENT WITH A MITROFLOW LXA25, VIA A SUBMISSION FROM THE TGA. THE REPORTED INFORMATION WAS AS FOLLOWS. DATE OF IMPLANT: (B)(6) 2014. CLINICAL EVENT INFORMATION: THE DEATH OF [REDACTED] WAS REPORTED TO THE CORONER. THE MANNER AND CAUSE OF [REDACTED] DEATH WAS FOUND TO BE 'PROSTHETIC HEART VALVE FAILURE'. A DEATH DUE TO THE FAILURE OF A MEDICAL DEVICE IS REPORTABLE TO THE TGA. THE DECEASED WAS REPORTEDLY A (B)(6) YEAR OLD WOMAN WITH A PRIOR MEDICAL HISTORY OF AORTIC VALVE REPLACEMENT IN [REDACTED], HYPOTHYROIDISM, DEPRESSION, HYPERTENSION, AND HYPERLIPIDAEMIA. THE DECEASED HAD REPORTEDLY BEEN UNSTEADY ON HER FEET FOR A COUPLE OF DAYS, AND IN THE AFTERNOON OF [REDACTED] WAS SEEN TO BE STRUGGLING BY HER HUSBAND. THE DECEASED THEN COLLAPSED AND SLUMPED IN HER CHAIR. AN AMBULANCE WAS CALLED, AND THE PATIENT WAS TAKEN TO [REDACTED] HOSPITAL FOR EMERGENCY TREATMENT. ON ARRIVAL AT HOSPITAL THE PATIENT WAS IN CARDIORESPIRATORY ARREST AND EXTENSIVE RESUSCITATION WAS ATTEMPTED. A LIKELY DIAGNOSIS OF CARDIOGENIC SHOCK SECONDARY TO AN ACUTE CORONARY SYNDROME WAS MADE GIVEN THE PRESENCE OF CHEST PAIN AND T WAVE INVERSION

  Patient problems: Aortic Insufficiency; Death

  MAUDE report 9827522 ↗
• DeathMar 12, 2020Degraded; Leak/Splash; Degraded; Leak/Splash

  THE MANUFACTURER WAS MADE AWARE OF A SERIOUS ADVERSE EVENT WHICH INVOLVED A PATIENT WITH A MITROFLOW LXA25, VIA A SUBMISSION FROM THE TGA. THE REPORTED INFORMATION WAS AS FOLLOWS. DATE OF IMPLANT: (B)(6) 2014. CLINICAL EVENT INFORMATION: THE DEATH OF [REDACTED] WAS REPORTED TO THE CORONER. THE MANNER AND CAUSE OF [REDACTED] DEATH WAS FOUND TO BE 'PROSTHETIC HEART VALVE FAILURE'. A DEATH DUE TO THE FAILURE OF A MEDICAL DEVICE IS REPORTABLE TO THE TGA. THE DECEASED WAS REPORTEDLY A (B)(6) YEAR OLD WOMAN WITH A PRIOR MEDICAL HISTORY OF AORTIC VALVE REPLACEMENT IN [REDACTED], HYPOTHYROIDISM, DEPRESSION, HYPERTENSION, AND HYPERLIPIDAEMIA. THE DECEASED HAD REPORTEDLY BEEN UNSTEADY ON HER FEET FOR A COUPLE OF DAYS, AND IN THE AFTERNOON OF [REDACTED] WAS SEEN TO BE STRUGGLING BY HER HUSBAND. THE DECEASED THEN COLLAPSED AND SLUMPED IN HER CHAIR. AN AMBULANCE WAS CALLED, AND THE PATIENT WAS TAKEN TO [REDACTED] HOSPITAL FOR EMERGENCY TREATMENT. ON ARRIVAL AT HOSPITAL THE PATIENT WAS IN CARDIORESPIRATORY ARREST AND EXTENSIVE RESUSCITATION WAS ATTEMPTED. A LIKELY DIAGNOSIS OF CARDIOGENIC SHOCK SECONDARY TO AN ACUTE CORONARY SYNDROME WAS MADE GIVEN THE PRESENCE OF CHEST PAIN AND T WAVE INVERSION

  Patient problems: Aortic Insufficiency; Death

  MAUDE report 9827514 ↗
• InjuryFeb 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO RECEIVED A MITROFLOW LXA25 IN 2014, EXPERIENCED ENDOCARDITIS (DATE OR TIMELINE OF THE EVENT IS UNKNOWN). BASED ON THE INFORMATION RECEIVED, THE DEVICE WAS REPORTEDLY EXPLANTED.

  Patient problems: Endocarditis

  MAUDE report 9746245 ↗
• InjuryFeb 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THAT A PATIENT WHO RECEIVED A MITROFLOW LXA25 IN 2014, EXPERIENCED ENDOCARDITIS (DATE OR TIMELINE OF THE EVENT IS UNKNOWN). BASED ON THE INFORMATION RECEIVED, THE DEVICE WAS REPORTEDLY EXPLANTED.

  Patient problems: Endocarditis

  MAUDE report 9746211 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WAS IMPLANTED WITH A MITROFLOW LXA25 SN (B)(4) ON (B)(6) 2013 AT (B)(6) MEDICAL CENTER (B)(6). AT 2 YEARS FOLLOW-UP VALVE SHOWED FAILURE WITH SEVERE BIO-PROSTHETIC AORTIC STENOSIS. ON (B)(6) 2015 A TAVI WAS PERFORMED AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: Aortic Valve Stenosis

  MAUDE report 8839641 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WAS IMPLANTED WITH A MITROFLOW LXA25 SN (B)(4) ON (B)(6) 2013 AT (B)(6) MEDICAL CENTER (B)(6). AT 2 YEARS FOLLOW-UP VALVE SHOWED FAILURE WITH SEVERE BIO-PROSTHETIC AORTIC STENOSIS. ON (B)(6) 2015 A TAVI WAS PERFORMED AT (B)(6) MEDICAL CENTER IN (B)(6).

  Patient problems: No Information

  MAUDE report 8839625 ↗
• InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO A MITROFLOW VALVE LXA25 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A MITROFLOW VALVE DLA23 ON (B)(6) 2014. NO FURTHER EVENT DETAILS WERE PROVIDED. THIS CASE IS BEING REPORTED TO FDA IN A CONSERVATIVE MANNER.

  Patient problems: No Information

  MAUDE report 8317656 ↗
• InjuryMay 15, 2018Gradient Increase; Material Too Rigid or Stiff; Material Deformation; Gradient Increase; Material Too Rigid or Stiff; Material Deformation

  A 25 MM MITROFLOW LXA WAS IMPLANTED ON (B)(6) 2010. ON (B)(6) 2018, THE VALVE WAS EXPLANTED DUE TO CRITICAL AORTIC STENOSIS. URGENT SURGERY WAS REQUIRED DUE TO RESPIRATORY COLLAPSE.

  Patient problems: Aortic Valve Stenosis; Respiratory Failure

  MAUDE report 7515715 ↗
• InjuryNov 23, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED ON 26 OCT 2016 THROUGH PATIENT TRACKING FORM FOR PATIENT WHO HAD A MITROFLOW LXA25 IMPLANTED IN 2012. DETAILS AS: LXA25 SN # (B)(4) WAS IMPLANTED ON (B)(6) 2012 AT (B)(6). R5-023 SN # (B)(4) WAS IMPLANTED ON (B)(6) 2016 AT (B)(6). NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Information

  MAUDE report 6126457 ↗