SJM™ RSAR-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734009430), received between Jul 8, 2021 and Mar 3, 2023 — classified as 1 death, 10 injuries.

The most frequently reported specific device problem is “Backflow” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Adverse 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) 2023, A 28MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. AFTER THE PROCEDURE, THE PATIENT HAD AN ONSET OF BRADY-ASYSTOLE TREATED WITH TEMPORARY PACEMAKER. THE PATIENT NEEDED THE TEMPORARY PACEMAKER IN THE INTENSIVE CARE UNIT (ON (B)(6) 2023). IT IS UNKNOWN IF A PERMANENT PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Asystole

  MAUDE report 16478959 ↗
• InjuryJan 16, 2023Adverse 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 RIGID SADDLE RING WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2022, PAROXYSMAL ATRIAL FIBRILLATION WAS DISCOVERED AFTER THE PROCEDURE BY ELECTROCARDIOGRAM AND THE PATIENT WAS TREATED WITH AMIODARONE. A TEMPORARY PACEMAKER WAS USED TO TREAT THE FIBRILLATION, AND THE HOSPITAL STAY WAS PROLONGED TO MONITOR THE RHYTHM. THE PATIENT IS REPORTED TO BE DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation

  MAUDE report 16178515 ↗
• InjuryNov 30, 2022Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6), (B)(6). (B)(6), (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED WITH NO REPORTED COMPLICATIONS. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT PROLONGED PROCEDURE TIME WAS REPORTED. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT HAD CLINICAL SIGNS FOR STROKE WITHOUT NOTED SIGNS OF STROKE ON A CARDIOVASCULAR COMPUTED TOMOGRAPHY SCAN; THE PATIENT WAS DIAGNOSED WITH A TRANSIENT ISCHEMIC ATTACK (TIA). HOWEVER, NO TREATMENT WAS REQUIRED/PERFORMED. ON (B)(6) 2022, SINOATRIAL BLOCK WAS OBSERVED AND THE PATIENT RECEIVED MEDICATION AND A PACEMAKER WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Air Embolism; Heart Block; Stroke/CVA; Transient Ischemic Attack

  MAUDE report 15886398 ↗
• InjuryOct 4, 2022Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2022, A 28MM RIGID SADDLE RING WAS SELECTED FOR AN IMPLANTED IN A PATIENT WITH MITRAL VALVE INSUFFICIENCY WITH STENOSIS DUE TO ENDOCARDITIS. DURING THE PROCEDURE, AFTER THE DEVICE WAS IMPLANTED, A WATER INJECTION PRESSURE TEST SHOWED MILD TO MODERATE REGURGITATION. AFTER ADJUSTING THE RING, THE RESULT WAS STILL NOT SATISFACTORY. DEVICE WAS EXPLANTED AND A NEW 28MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15540097 ↗
• InjuryAug 11, 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 A 28MM RIGID SADDLE RING WAS IMPLANTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT HAD CHEST PAIN AFTER COUGHING. THORAX TOMOGRAPHY SHOWED A HEMOTHORAX IN THE RIGHT SIDE OF UNKNOWN ORIGIN. AN EMERGENT OPERATION WAS DONE. AFTER THE OPERATION, THE PATIENT HAD HYPOVOLEMIC SHOCK AND BLOOD TRANSFUSIONS WERE PERFORMED WITH THE PATIENT RETURNING TO STABLE CONDITION. THE RING WAS REPORTED TO BE WORKING AS INTENDED. AT 1 YEAR FOLLOW-UP PERFORMED ON (B)(6) 2022, THE PATIENT WAS REPORTED TO BE IN GOOD AND STABLE CONDITION.

  Patient problems: Hemothorax

  MAUDE report 15211403 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 28MM RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT EXPERIENCED LONG EPISODE OF TACHYARRHYTHMIA. MEDICATIONS WERE STARTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE EVENT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 14141440 ↗
• InjuryJan 14, 2022Adverse 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 RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING SUDDEN THORACIC SWELLING. A CT WAS PERFORMED AND A THORAX, SUBCUTANEOUS AND INTRATHORACIC HEMATOMA WAS NOTED. A STENT WAS IMPLANTED ON (B)(6) 2021 HOWEVER, SWELLING WAS NOTABLY MORE. ANOTHER CT WAS PERFORMED AN SHOWED AN INCREASE OF INTRATHORACIC HEMATOMA AND WAS SURGICALLY REMOVED ON (B)(6) 2022. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION POST PROCEDURE. ON (B)(6) 2022, A CHEST X-RAY WAS PERFORMED A LIMITED PNEUMOTHORAX WAS NOTED. A CHEST DRAIN WAS INSERTED. LATERA FOLLOW-UP CHEST X-RAY WAS PERFORMED AND NO PNEUMOTHORAX WAS NOTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ((B)(4)).

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 13258699 ↗
• InjuryNov 24, 2021Backflow; Backflow

  SUBSEQUENT TO THE INITIALLY FILED INFORMATION, THE FOLLOWING INFORMATION WAS RECEIVED, ON 26 OCTOBER 2021, A 28 MM SJM RIGID SADDLE RING WAS CHOSEN FOR IMPLANT FOR A MITRAL VALVE REPAIR. AFTER THE DEVICE WAS IMPLANTED AND THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS (CPB), IT WAS OBSERVED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) THAT THERE WAS SIGNIFICANT MITRAL REGURGITATION PRESENT. THE PATIENT WAS PLACED BACK ON CPB, AND THE DEVICE WAS EXPLANTED AND REPLACED WITH A 24 MM SJM RIGID SADDLE RING TO RESOLVE THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY PERMANENT IMPAIRMENT OR DAMAGE AS A RESULT OF THIS EVENT. THE PATIENT WAS HOSPITALIZED TO RECOVER FOLLOWING THIS PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE. THE PATIENT HAD A PAST MEDICAL HISTORY OF RHEUMATIC HEART DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12870918 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 16 AUGUST 2021, A 28MM SJM RIGID SADDLE RING WAS IMPLANTED. THERE WERE NO COMPLICATIONS NOTED DURING THE IMPLANT PROCEDURE. ON 19 AUGUST 2021, THE PATIENT REQUIRED DIURETICS DUE TO EDEMA EXTREMITIES. THE EDEMA WAS MOST LIKELY DO TO THE PROCEDURE RELATED TO A DISTURBED FLUID BALANCE. THE PATIENT RECEIVED DIURETICS AND COMPRESSION STOCKINGS TO RESOLVE THE EDEMA. THE PATIENT WAS REPORTED TO BE RECOVERING AND WAS DISCHARGED ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 09/02/21, ON (B)(6) 2021, THE PRESENTED UNABLE TO WALK MUCH AND EXPERIENCING SHORTNESS OF BREATH AND STRUGGLING TO MANAGE SELF-CARE. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND SHOED A PERICARDIAL FLUID AND A PERICARDIOCENTESIS. THE PATIENT'S BLOOD PRESSURE INCREASED. ANOTHER TTE WAS PERFORMED NO MORE PERICARDIAL FLUID WAS NOTED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Dyspnea; Fatigue; Pericardial Effusion; Swelling/ Edema

  MAUDE report 12407619 ↗
• DeathJul 14, 2021Adverse 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 THAT ON (B)(6) 2021, CRANIAL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED INFARCT ON RIGHT HEMISPHERE. PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE. THE STROKE WAS IN THE RIGHT MEDIAL STEAM AREA WITH EDEMATOUS COMPRESSION OF THE LATERAL VENTRICLE AND CENTERLINE SHIFT. PATIENT WAS ADMINISTERED HEPARIN INFUSION. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER MANAGEMENT. ON (B)(6) 2021, PATIENT WAS EXTUBATED AND TRANSFERRED TO PALLIATIVE CARE UNIT. ON (B)(6) 2021, THE PATIENT DIED DUE TO THE CONSEQUENCES OF THE STROKE AND COMORBIDITIES. THE CAUSE OF THE STROKE WAS UNKNOWN. THERE WAS NO ALLEGATION OF MALFUNCTION MADE AGAINST THE RIGID SADDLE RING. NO ADDITIONAL INFORMATION WAS PROVIDED. CLINICAL INFORMATION: (B)(6).

  Patient problems: Abdominal Pain; Ischemia Stroke

  MAUDE report 12165603 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 28MM SJM RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WITH PRE-OP KNOWN HYPONATREMIA EXPERIENCED PROGRESSIVE HYPONATREMIA. THE PATIENT WAS EXPERIENCING NAUSEA AND EMESIS. ON (B)(6) 2021, IV SODIUM SUBSTITUTION WAS ADMINISTRATED. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED BUT CANNOT BE OBTAINED. ((B)(4)).

  Patient problems: Hyponatremia; Nausea

  MAUDE report 12135545 ↗