SJM™ Mechanical Heart Valve A-101 (REF 19A-101)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734005838), received between Oct 23, 2023 and Oct 23, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 1997, A 19MM SJM STANDARD MECHANICAL HEART VALVE WAS IMPLANTED DURING AN AORTIC VALVE REPLACEMENT. ON (B)(6) 2023, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED, WHICH SHOWED THAT THERE WAS A FUNCTIONAL ISSUE WITH ONE OR TWO OF THE LEAFLETS. THE PATIENT WAS RECOMMENDED TO RECEIVE A VALVE REPLACEMENT. THE PATIENT WAS SCHEDULED FOR A COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) TO ASSESS THE NEED FOR A VALVE REPLACEMENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 17987133 ↗