SJM™ SARP-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05414734007511), received between Dec 20, 2019 and Nov 13, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Lack of Effect” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM SEGUIN SEMI-RIGID SADDLE RING WAS CHOSEN FOR A MITRAL VALVE REPAIR. THE RING WAS IMPLANTED, BUT REGURGITATION DID NOT SUBSIDE. THE RING WAS REMOVED BY OPEN HEART SURGERY, AND A NEW NON-ABBOTT VALVE WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18121150 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - ARB PMCF. PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, 30MM RIGID SADDLE RING WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THERE WAS DIFFICULTIES WITH THE RING HOLDER GETTING LOOSE. THE DEVICE WAS SUCCESSFULLY IMPLANTED IN A PATIENT WITH LEAFLET RESTRICTION. POST-IMPLANT, SUBSTANTIAL LEAKAGE WAS STILL PRESENT OVER THE ENTIRE CLOSING LINE. A SMALLER RING WAS NOT POSSIBLE. THEREFORE, THE SURGEON ELECTED TO REPLACE THE MITRAL VALVE WITH A NON-ABBOTT DEVICE. ON (B)(6) 2023, RIGHT SIDED OCCLUSION OF A DISTAL M3 BRANCH WAS SUSPECTED, HOWEVER INACCESSIBLE FOR THROMBECTOMY. ANEURYSM WAS OBSERVED IN THE DISTAL INTERNAL CAROTID RIGHT ARTERY WITH A DIAMETER OF 14MM; VASCULAR SURGERY WAS CONSULTED. THE PATIENT EXPERIENCED LEFT ARM PARALYSIS. ON (B)(6) 2023, THE PATIENT HAD RECOVERY OF MOBILITY. ON (B)(6) 2023, ATRIAL FIBRILLATION AND INCOMPLETE RIGHT BUNDLE BRANCH BLOCK WAS OBSERVED, HOWEVER NO TREATMENT WAS REQUIRED. IN ADDITION, ANEMIA WITH DECREASED HEMOGLOBIN DOWN TO 4.5MMOL/L WAS OBSERVED AND THE PATIENT WAS TRANSFUSED 1 UNIT PACKED RED BLOOD CELLS. ON (B)(6) 2023, FLUID OVERLOAD WAS OBSERVED AND THE PATIENT'S DIURETIC DOSE WAS INCREASED. ON (B)(6) 2023, DELIR

  Patient problems: Anemia; Aneurysm; Atrial Fibrillation; Encephalopathy; Heart Block; Stroke/CVA

  MAUDE report 16559950 ↗
• InjuryNov 30, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  CLINICAL STUDY PATIENT ID: (B)(6), (B)(6). (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM SEGUIN ANNULOPLASTY RING WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, IN THE EVENING, THE PATIENT DEVELOPED SEPTIC FEVER UP TO 40 DEGREES CELSIUS. ECHOCARDIOGRAM SAME DAY SHOWED NO PROBLEMS WITH VALVE. ON (B)(6), NO INFECTION ON THE IMPLANT SITE BUT A POSITIVE BLOOD CULTURE WAS NOTED. ECHOCARDIOGRAM ON (B)(6) 2022 SHOWED VEGETATIONS ON SADDLE RING AND EARLY POSTOPERATIVE ENDOCARDITIS WAS DIAGNOSED. THE PATIENT WAS PUT ON ANTIBIOTIC THERAPY. ON (B)(6) 2022, DEVICE WAS EXPLANTED AND A NON-ABBOT DEVICE IMPLANTED DUE TO MITRAL VALVE ENDOCARDITIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Endocarditis; Fever

  MAUDE report 15886668 ↗
• InjuryNov 4, 2022Lack of Effect; Lack of Effect

  CLINICAL INFORMATION: CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(6) - 161 (B)(4). IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT HAD A 30MM SEGUIN SEMI-RIGID SADDLE RING IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS REPORTED TO HAVE REDUCED HEMOGLOBIN LEVELS AND ANEMIA. NO TREATMENT WAS PROVIDED. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT HAD WORSENING MITRAL VALVE REGURGITATION, DISCOVERED BY TRANSTHORACIC ECHOCARDIOGRAM. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR WORSENING ANEMIA, AND WAS ADMINISTERED A BLOOD TRANSFUSION. ON (B)(6) 2021, IT WAS REPORTED THAT THE 20MM SEGUIN SEMI-RIGID SADDLE RING WAS EXPLANTED AND AN UNKNOWN VALVE WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH COAGULOPATHY. THE COAGULOPATHY WAS RESOLVED THE SAME DAY WITH THE ADMINISTRATION OF PPSB. REGURGITATION WAS DECLARED RESOLVED (B)(6) 2021. IT IS SUSPECTED BUT NOT FINALLY CONFIRMED THAT MECHANICAL HEMOLYSIS AFTER MITRAL VALVE RECONSTRUCTION CAUSED THE PATIENT ANEMIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Anemia; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15739523 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. ON (B)(6) 2022, POST IMPLANT DECREASED HEMOGLOBIN VALUES WERE NOTED AND WAS ADMINISTRATED 2 PACKS OF RED CELL CONCENTRATE. LATER DUE TO A SUSPECTED BLEEDING DISORDER THE PATIENT WAS ADMINISTRATED 4 PACKS OF FRESH FROZEN PLASMA (FFP). THE RING IS PERFORMING AS INTENDED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED AND REPORTED TO BE IN STABLE CONDITION. ((B)(4)).

  Patient problems: Confusion/ Disorientation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13497852 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE HOSPITAL AND HAEMOLYTIC ANEMIA WAS NOTED REQUIRING HOSPITALIZATION. IT IS THOUGHT THIS WAS DUE TO THE IMPLANTED ANNULOPLASTY RING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION IS PENDING. (B)(4).

  Patient problems: Hemolytic Anemia

  MAUDE report 13346282 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE, ABNORMAL ROTEM VALUE WAS NOTED AND IV MEDICATIONS WERE ADMINISTRATED THE SAME DAY. ON (B)(6) 2021, CHYLOTHORAX WAS REPORTED AND A RECUMBENT DRAINAGE WAS PERFORMED. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 AND STARTED REHABILITATION. THE RING IS PERFORMING AS INTENDED. (B)(4).

  Patient problems: Coagulation Disorder

  MAUDE report 12896603 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE AFTER THE PATIENT ARRIVED TO THE INTENSIVE CARE UNIT (ICU) A CIRCUMFLEX ARTERY OCCLUSION WAS NOTED. THE PATIENT DIDN'T PRESENT WITH ANY KNOWN SYMPTOMS. A CORONAROGRAPHY WAS PERFORMED. THE CAUSE OF THE CIRCUMFLEX ARTERY OCCLUSION WERE THE STITCHES THAT THE PHYSICIAN PLACED TO FIX THE RING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED ON (B)(6) 2021. (B)(4).

  Patient problems: Obstruction/Occlusion

  MAUDE report 12852763 ↗
• InjuryOct 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 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. DURING THE IMPLANT PROCEDURE, COAGULOPATHY WAS NOTED DURING PROCEDURE AND PATIENT WAS ADMINISTRATED MEDICATIONS. POST PROCEDURE, FIBRINOGENEMIA, ACIDOSIS WAS TERMINATED WITH SODIUM BICARBONATE AND SEIZURE WERE REPORTED. THE CAUSE OF THE SEIZURE IS UNKNOWN BUT THE PATIENT WAS GIVEN PROPOFOL. ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING POST OPERATIVE DELIRIUM AND WAS GIVEN HALOPERIDOL. ON (B)(6) 2021, ANURIA RENAL FAILURE WAS NOTED AND WAS GIVEN IV MEDICATIONS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT IS EXPECTED TO BE DISCHARGED ON (B)(6) 2021. ((B)(4)).

  Patient problems: Coagulation Disorder; Convulsion/Seizure; Renal Failure

  MAUDE report 12696773 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST IMPLANT, ABNORMAL ROTEM LAB WAS NOTED. THE PATIENT WAS ADMINISTRATED PROTHROMBIN COMPLEX CONCENTRATE (PPSB). NO INFORMATION WAS PROVIDED TO CONFIRM IF THE RING IS FUNCTIONING AS INTENDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED. CRD_985 - ARB PMCF; (B)(4).

  Patient problems: Coagulation Disorder

  MAUDE report 12637343 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. DURING PROCEDURE, AFTER PLACING THE DEVICE IN THE PATIENT COAGULOPATHY WAS REPORTED AND THE PATIENT WAS GIVEN FIBROGEN AND PPSB. THE PATIENT DOES NOT HAVE A HISTORY OF A CLOTTING DISORDER. ON (B)(6) 2021, ATRIAL FLUTTER WAS NOTED AND WAS TERMINATED BY CARDIOVERSION. THE PATIENT HAS A TEMPORARY PACEMAKER THAT WAS PLACED DURING IMPLANT PROCEDURE THAT CAN BE SWITCHED TO PERMANENT IF NEEDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND HAS BEEN DISCHARGED. IT IS UNKNOWN THE SOURCE OF THE ATRIAL FLUTTER.(CRD_985 - ARB PMCF; DE4019-163; (B)(4).

  Patient problems: Atrial Flutter; Coagulation Disorder

  MAUDE report 12546566 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE, WORSENING AFIBRINOGENEMIA WAS NOTED. THE PHYSICIAN NOTED THAT AS SOON AS A PATIENT SHOWS AN ABNORMAL VALVE, THE COAGULATION IS OPTIMIZED. THE EVENT WAS REPORTED BASED OF THE CLINICAL STUDY PROTOCOL. THERE IS NO BASELINE VALVE FOR THIS PATIENT TO CONFIRM IF THERE IS REALLY A DETERIORATION IN HEALTH. THE PATIENT WAS ADMINISTRATED MEDICATION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED. (CRD_985 - ARB PMCF; (B)(4)).

  Patient problems: Coagulation Disorder

  MAUDE report 12442950 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIALLY FILED INFORMATION, THE FOLLOWING INFORMATION WAS RECEIVED ON (B)(6) 2021: IT WAS REPORTED THAT THE AFIBRINOGENEMIA DIAGNOSIS IN THIS EVENT BELOW WAS USED TO DOCUMENT TEMPORARY CHANGES IN FIBRINOGEN LEVELS IN THE BLOOD. THEREFORE THE INFORMATION REPORTED INITIALLY REMAINS A REPORTABLE EVENT.

  Patient problems: Coagulation Disorder

  MAUDE report 12438999 ↗
• 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 30MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. DURING PROCEDURE, AFTER THE DEVICE WAS PLACED IN THE PATIENT A LAB ANALYSIS SHOWED ABNORMAL FIBRINOGEN VALUE AND COAGULOPATHY WAS NOTED. THE PATIENT WAS TRANSFUSED FRESH FROZEN PLASMA. IT IS UNKNOWN WHAT CAUSED THE BLEEDING/CLOTTING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND HAS BEEN DISCHARGED. (B)(4)

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12421447 ↗
• InjuryDec 20, 2019Backflow; Backflow

  ON (B)(6) 2019, A 30MM SEGUIN ANNULOPLASTY RING WAS IMPLANTED AS PART OF A MITRAL VALVE REPAIR CASE. ON POST-OPERATION ECHO, THE PATIENT HAD SIGNIFICANT MITRAL REGURGITATION. ON (B)(6) 2019, THE RING WAS EXPLANTED AND AN UNKNOWN SIZED UNKNOWN MECHANICAL HEART VALVE WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9504035 ↗