SJM™ SARP-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734007559), received between Oct 4, 2022 and Oct 4, 2022 — classified as 1 injury.

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

• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 28 MM SEGUIN ANNULOPLASTY RING WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST DUE TO MASSIVE PNEUMOTHORAX AND SUBCUTANEOUS EMPHYSEMA AND WAS TREATED WITH ADRENALINE AND HEART MASSAGE FOR 10MINS BEFORE RETURN OF SPONTANEOUS CIRCULATION (ROSC) OCCURRED. THE PATIENT WAS INTUBATED AND BROUGHT TO THE INTENSIVE CARE UNIT FOR TWO DAYS. PATIENT WAS EXTENUATED, WITHOUT NEUROLOGICAL DEFECT. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED RIGHT PNEUMOTHORAX AND WAS DRAINED. NO VALVULAR PROBLEM NOTED ON ECHOCARDIOGRAM AND THERE WAS GOOD CONTRACTILITY AND FUNCTION OF THE VENTRICLES. NO PERICARDIAL EFFUSION WAS OBSERVED, AND THE DEVICE WAS WORKING AS INTENDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Cardiac Arrest; Pneumothorax

  MAUDE report 15540276 ↗