SJM™ SARP-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734007504), received between Aug 26, 2021 and Feb 3, 2023 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THERE HAD BEEN NO DIFFICULTY EXPERIENCED IMPLANTING THE 28MM SEGUIN SEMI-RIGID SADDLE RING. THE RING HAD BEEN SIZED USING A 501 RING SIZER SET AND THE HOLDER HANDLE WAS USED DURING PROCEDURE. THE PATIENT WAS IN GOOD CONDITION AT THE TIME OF REPORT. THE CAUSE OF THE PATIENT'S PLEURAL EFFUSION IS UNKNOWN.

  Patient problems: Pleural Effusion

  MAUDE report 16294269 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM SEGUIN SEMI-RIGID SADDLE RING WAS CHOSEN FOR IMPLANT IN THE MITRAL VALVE. THIS PROCEDURE WAS PERFORMED DUE TO HISTORY OF MITRAL VALVE PROLAPSE. A RING SIZER SET WAS USED DURING PROCEDURE. THE MITRAL VALVE REPAIR INCLUDED A CLEFT CLOSURE. THE POSTERIOR LEAFLET WAS REPAIRED. THE MITRAL VALVE REPAIR INCLUDED SUBVALVULAR REPAIRS, INCLUDING CHORDAL REPLACEMENT WITH ARTIFICIAL CHORDAE OR SUTURE. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS REPORTED. THE RING WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A REPEATED MITRAL VALVE PROLAPSE. ON (B)(6) 2022, TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH WAS ABNORMAL. ON (B)(6) 2022, THE DEVICE WAS EXPLANTED, AND THE VALVE WAS REPAIRED. A 30MM SEGUIN SEMI-RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED TO RESOLVE THIS EVENT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15321546 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 28MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE, HYPOFIBRINOGENEMIA WAS NOTED. THE PATIENT WAS TRANSFUSED 4 UNITS OF FRESH FROZEN PLASMA (FFP). THE PATIENT DID NOT PRESENT WITH ANY BLOOD CLOTS OR BLOOD LOSS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED. (B)(6).

  Patient problems: Coagulation Disorder

  MAUDE report 13414761 ↗
• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 28MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. ON (B)(6) 2021, AN ISCHEMIC STROKE WAS REPORTED. AN ECHOCARDIOGRAM WAS PERFORMED AND NO INTRACARDIAC THROMBUS OR THROMBUS ON ANNULOPLASTY RING HAVE BEEN FOUND. THE PATIENT DID EXPERIENCE SOME CONFUSION. THE PHYSICIAN STATED THE CAUSE OF THE ISCHEMIC STROKE IS UNKNOWN AND THERE IS NO CERTAIN CORRELATION WITH THE PROCEDURE OR WITH THE ANNULOPLASTY RING. THERE WAS NO MEDICAL INTERVENTION PERFORMED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT DOESN'T HAVE A HISTORY OF STROKES BUT HAS A HISTORY OF MEDICALLY TREATED HYPERTENSION AND LONG-STANDING PERSISTENT ATRIAL FIBRILLATION (AF). DUE TO THE PROXIMITY TO THE IMPLANT PROCEDURE, THIS EVENT IS TO BE CONSERVATIVELY REPORTED AS THE CAUSE OF THE STROKE REMAINS UNKNOWN. ((B)(6) PMCF; (B)(6)).

  Patient problems: Confusion/ Disorientation; Ischemia Stroke

  MAUDE report 13057014 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 28MM SJM SÉGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE, ABNORMAL LAB VALUE FOR FIBRINOGENEMIA WAS NOTED. THE PATIENT WAS ADMINISTERED FRESH FROZEN PLASMA INTRAVENOUSLY. IT IS UNKNOWN WHAT CAUSED THE ABNORMAL LAB VALUE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND HAS BEEN DISCHARGED. INFORMATION WAS RECIEVED THAT INDICATED THAT THE AFIBRINOGENEMIA DIAGNOSIS IN THIS EVENT WAS USED TO DOCUMENT TEMPORARY CHANGES IN FIBRINOGEN LEVELS IN THE BLOOD. NO ADDITIONAL INFORMATION WAS PROVIDED. ((B)(4)).

  Patient problems: Coagulation Disorder

  MAUDE report 13025193 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021 A 28MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE THE PATIENT RECEIVED 4 UNITS OF FRESH FROZEN PLASMA INTRAVENOUSLY DUE TO LOW FIBRINOGEN LEVELS. IT WAS NOTED THAT THE PATIENT WAS NEWLY DIAGNOSED WITH FIBRINOGENEMIA. PATIENT¿S FIBRINOGEN LEVEL WAS 1.2 G/L. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. INFORMATION WAS RECEIVED THAT INDICATED THAT THE AFIBRINOGENEMIA DIAGNOSIS IN THIS EVENT WAS USED TO DOCUMENT TEMPORARY CHANGES IN FIBRINOGEN LEVELS IN THE BLOOD. NO ADDITIONAL INFORMATION WAS PROVIDED. (CRD_985 - ARB PMCF; DE4019-164; (B)(4).

  Patient problems: Coagulation Disorder

  MAUDE report 13025167 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 28MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. DURING PROCEDURE, COAGULOPATHY WAS REPORTED. THE PATIENT RECEIVED IV MEDICATIONS. POST PROCEDURE, TACHYCARDIA WAS REPORTED AND WAS TERMINATED WITH AMIODARON. ON (B)(6) 2021, ATRIAL FIBRILLATION WAS REPORTED AND THE PATIENT WAS GIVEN ORAL MEDICATION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND HAS BEEN DISCHARGED. ((B)(4)).

  Patient problems: Atrial Fibrillation; Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 12422758 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 28MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE COAGULOPATHY WAS NOTED AND THE PATIENT WAS FRESH FROZEN PLASMA (FFP) TRANSFUSED 4 TIMES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND HAS BEEN DISCHARGED. (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12421597 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 28MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE, COAGULOPATHY WAS REPORTED AND THE PATIENT WAS GIVEN IV MEDICATIONS AND PATIENT PRESENTED IN BRADY-TACHY-ARRHYTHMIA AND A PACEMAKER WAS IMPLANTED. ON (B)(6) 2021, RHYTHMS DISORDER WAS NOTED AND WAS TREATED WITH MAGNESIUM AND AMIODARONE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. (CRD_985 - ARB PMCF; DE4019-157; R622091501, R622092301, R622088301).

  Patient problems: Atrial Flutter; Bradycardia; Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 12407685 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 28MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. DURING PROCEDURE HYPOFIBRINOGENEMIA, THROMBOCYTOMIA AND ANEMIA LEADING TO BLEEDING. THE PATIENT RECEIVED A PLATELET TRANSFUSION AND MEDICATIONS. THE PATIENT HAS A HISTORY OF THE FOLLOWING; ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, NON-ISCHEMIC CARDIOMYOPATHY. OTHER MEDICAL CONDITIONS: HYPERTENSION, HYPERCHOLESTEROLEMIA, THROMBOSIS, PERIPHERAL VASCULAR DISEASE, KIDNEY AND LIVER DISEASE. THE PATIENT IS ALIVE AND SINCE HAS BEEN DISCHARGED FROM THE HOSPITAL. (B)(4).

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Thrombocytopenia

  MAUDE report 12372851 ↗