MITROFLOW LXA27Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00896208000139), received between Aug 7, 2018 and Sep 3, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Degraded” (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 5 most recent of 5 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 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 14TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422540 ↗
• 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 8TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12422135 ↗
• 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 8TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12416408 ↗
• 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 14TH SERIAL # PROVIDED. IMPLANT TIME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12411620 ↗
• InjuryAug 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A MITROFLOW LXA27 WAS IMPLANTED ON (B)(6) 2014. THE VALVE WAS EXPLANTED APPROXIMATELY 4 YEARS LATER. THE REASON FOR EXPLANT WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 7760172 ↗