SJM™ Mechanical Heart Valve A-101 (REF 21A-101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734005951), received between Jul 21, 2020 and Aug 27, 2024 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathAug 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2007, A 21MM SJM MECHANICAL HEART VALVE WAS IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 20076826 ↗
• MalfunctionJul 21, 2020Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2020 DR. (B)(6) IMPLANTED 21MM MECHANICAL HEART VALVE IN THE AORTIC POSITION-(B)(4) AND A 27MM MECHANICAL HEART VALVE IN THE MITRAL POSITION -(B)(4). ON (B)(6) 2020, PATIENT CAME BACK EXPERIENCING SHORTNESS OF BREATH AND CHEST DISCOMFORT. AFTER INVESTIGATION IT WAS FOUND THAT ONE LEAFLET OF AORTIC VALVE IS NOT WORKING. AN EXPLANT SURGERY IS SCHEDULED FOR (B)(6) 2020.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 10302239 ↗