MITROFLOW DLA27Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00896208000191), received between Oct 21, 2016 and Sep 3, 2021 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2021Degraded; Degraded

  ON 5 AUG 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 13TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422509 ↗
• 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 11TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12417101 ↗
• 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 13TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12411647 ↗
• DeathDec 7, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A MITROFLOW DLA27 WAS IMPLANTED ON (B)(6) 2017 VIA MEDIAN-STERNOTOMY. ON (B)(6) 2017, THE PATIENT DIED OF CARDIOVASCULAR MORTALITY DUE TO UNKNOWN CAUSE.

  Patient problems: Death; Heart Failure

  MAUDE report 7096891 ↗
• InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2016 A MITROFLOW DLA VALVE WAS IMPLANTED (27MM) VIA MINI-STERNOTOMY. ON (B)(6) 2017 THE PATIENT EXHIBITED MYOCARDIAL INFARCTION- NON Q WAVE. THIS EVENT WAS REPORTED TO THE MANUFACTURER ON 05-APR-2017.

  Patient problems: Myocardial Infarction

  MAUDE report 6549615 ↗
• InjuryDec 21, 2016Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING ON (B)(6) 2016 ABOUT THE FOLLOWING: ON (B)(6) 2016, MITROFLOW DLA SIZE 27, SN# (B)(4) WAS IMPLANTED AT AORTIC POSITION. ON (B)(6) 2016, CROWN PRT, SIZE 25, SN# (B)(4) WAS IMPLANTED AT THE SAME AORTIC POSITION AT SAME HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 6197222 ↗
• InjuryOct 21, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS NOTIFIED OF THE FOLLOWING INFORMATION ON 23 SEP 2016: A (B)(6) PATIENT WAS IMPLANTED WITH DLA27 AND MITROFLOW VALSALVA CONDUIT ON (B)(6) 2014. DLA27 WAS EXPLANTED ON (B)(6) 2016 AT PATIENT'S AGE OF (B)(6) AND REPLACED WITH MECHANICAL VALVE. PATIENT HAD SERIES OF EMBOLIC EVENTS LEADING TO APPROXIMATELY 5 STROKES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6049304 ↗