SJM™ RSAR-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05414734009454), received between Sep 23, 2021 and Apr 7, 2023 — classified as 1 death, 12 injuries.

The most frequently reported specific device problem is “Lack of Effect” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6). PATIENT SITE ID: (B)(6) (R744186201) IT WAS REPORTED THAT ON (B)(6) 2023, A 32MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED WITHOUT ANY REPORTED COMPLICATION. THE 32MM RIGID SADDLE RING WAS SIZED USING A RING SIZER SET. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT WAS SUFFERING FROM EMPHYSEMA THAT PROGRESSED AFTER EXTUBATING. A COMPUTED TOMOGRAPHY SCAN AND CHEST X-RAY WERE PERFORMED AND REVEALED A PNEUMOTHORAX. THE DECISION WAS MADE TO SLIGHTLY RE-POSITION THE PATIENT'S CHEST TUBE (INTERCOSTAL CATHETER) BY PULLING IT, TO RESOLVED THE PNEUMOTHORAX. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT. THE DIRECT CAUSE OF THE PATIENT'S PNEUMOTHORAX AND PATIENT'S PROGRESSIVE EMPHYSEMA ARE UNKNOWN, BUT THERE IS NO ALLEGATION AGAINST THE 32MM RIGID SADDLE RING.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Pneumothorax

  MAUDE report 16704903 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF, PATIENT SITE ID: DE4432 - 477, R744194801. . IT WAS REPORTED THAT ON 14 NOVEMBER 2023, A 32MM RIGID SADDLE RING WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023, THE PATIENT DEVELOPED A TACHYCARDIA POST OPERATIVELY. MEDICATION WAS ADMINISTERED. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Tachycardia

  MAUDE report 16704891 ↗
• DeathMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION : (B)(4). DUE TO THE PROXIMITY TO THE IMPLANT PROCEDURE THIS EVENT IS BEING CONSERVATIVELY REPORTED. IT WAS REPORTED THAT ON (B)(6) 2023, A 32MM RIGID SADDLE RING WAS SELECTED FOR IMPLANT. IT WAS NOTED THAT THE PATIENT'S PROCEDURE WAS COMPLETED SUCCESSFULLY. PREOPERATIVELY, THE PATIENT HAD PNEUMOCOCCAL PNEUMONIA AND DEVELOPED PULMONARY EDEMA. THE PATIENT REQUIRED EXTENSIVE ADHESIOLYSIS AND STACKING OF THE HOLE IN THE LUNG. THE PATIENT WAS ADMITTED TO INTENSIVE CARE POSTOPERATIVELY. SHORTLY AFTER, OBSTRUCTIVE SHOCK AND RESPIRATORY FAILURE OCCURRED, THE PATIENT WAS DIAGNOSED WITH A TENSION PNEUMOTHORAX DUE TO HOLE IN LUNG WITH ADHESION AFTER PNEUMONIA IN 2020. THE PATIENT REQUIRED EMERGENCY RE-THORACOTOMY BECAUSE OF BECOMING HEMODYNAMICALLY UNSTABLE DUE TO RIGHT VENTRICLE FAILURE. THE PATIENT ENDED UP IN CARDIOGENIC SHOCK DUE TO RIGHT VENTRICULAR FAILURE AND RESPIRATORY FAILURE DUE TO PULMONARY EDEMA. IN ADDITION, THE PATIENT HAD ACUTE RENAL INSUFFICIENCY AND A THROMBUS IN THE LEFT HEART EAR, FOR WHICH DALTEPARIN WAS ADMINISTERED IN THERAPEUTIC DOSES. THERE ARE NO THOUGHTS DOCUMENTED ON THE CAUSE OF THE THROMBUS. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT P

  Patient problems: Pneumothorax; Pulmonary Edema; Renal Failure

  MAUDE report 16504611 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, 32MM RIGID SADDLE RING WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023, THE PATIENT WAS REPORTED TO HAVE A 2ND DEGREE HEART BLOCK THAT PROGRESSED INTO A 1ST DEGREE HEART BLOCK WITH SINUS RHYTHM CONFIRMED BY ELECTROCARDIOGRAM (EKG). METOPROLOL WAS STOPPED, AND THE PATIENT HAD A PERMANENT PACEMAKER IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT IS REPORTED TO BE DISCHARGED. ON (B)(6) 2023, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION. MEDICATION WAS ADMINISTERED. IT IS THOUGHT THAT THE HEART BLOCK WAS PROBABLY NOT DUE TO DEVICE.

  Patient problems: Atrial Fibrillation; Heart Block

  MAUDE report 16492281 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023 A 32MM RIGID SADDLE RING WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE PATIENT HAD SIGNS OF A PERICARDITIS WHICH WAS TREATED WITH ADHESIOLYSIS. ON (B)(6) 2023 THE PATIENT HAD SYSTEMIC INFLAMMATORY RESPONSE SYNDROME POST PROCEDURE; NORADRENALIN DOSE WAS INCREASED. ON (B)(6) 2023, PNEUMOTHORAX RIGHT SIDED WAS NOTED, HOWEVER NO TREATMENT WAS PROVIDED. PATIENT STABLE AND THE DEVICE IS WORKING AS INTENDED.

  Patient problems: Pericarditis; Pneumothorax

  MAUDE report 16280751 ↗
• InjuryJan 9, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM RIDGED SADDLE RING WAS IMPLANTED. ON (B)(6) 2022, MITRAL VALVE INSUFFICIENCY WAS OBSERVED AFTER A MINI MITRAL VALVULOPLASTY. THE PATIENT EXPERIENCED DYSPNEA. ON (B)(6) 2022, THE MITRAL VALVE WAS EXPLANTED AND A NEW 31MM EPIC VALVE WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Arrhythmia; Dyspnea; Mitral Valve Insufficiency/ Regurgitation; Pulmonary Hypertension

  MAUDE report 16125562 ↗
• InjuryDec 12, 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, AN SJM RIGID SADDLE RING WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2022, ELECTROCARDIOGRAM (EKG) WAS PERFORMED AND REVEALED THAT THE PATIENT WAS EXPERIENCING TRANSIENT HEART BLOCK. A PERMANENT PACEMAKER WAS IMPLANTED AND THE PATIENTS BISOPROLOL MEDICATION WAS PAUSED. THE PATIENT WAS REPORTED TO BE DISCHARGED AND STABLE. A HEALTHCARE PROFESSIONAL HAS NOT STATED THAT THEY BELIEVE THE PATIENT EXPERIENCED ADVERSE HEALTH EFFECTS. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Block

  MAUDE report 15959442 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, A 32MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2022, THE PATIENT HAD A THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK AND A PACEMAKER WAS IMPLANTED. ON 05 NOVEMBER 2022, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PLEURAL EFFUSION AND SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Heart Block; Pleural Effusion

  MAUDE report 15848492 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_985 - ARB PMCF, PATIENT SITE ID: EU1671 - 347, R708040801, R708041101. IT WAS REPORTED THAT ON (B)(6) 2022, A 32MM RIGID SADDLE RING WAS IMPLANTED IN THE MITRAL VALVE. PATIENT HAD SECONDARY MITRAL VALVE DISEASE CAUSED BY LEFT ATRIAL ENLARGEMENT. THE SURGERY ALSO INCLUDED A TRICUSPID ANNULOPLASTY USING A NON-ABBOTT DEVICE. THE PATIENT HAD SECONDARY TRICUSPID VALVE DISEASE CAUSED BY LEFT-SIDED VALVE DISEASE. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS REPORTED. FOLLOWING PROCEDURE, PATIENT HAD LEFT VENTRICLE EJECTION FRACTION (LVEF) OF 35%. THIS EVENT LED TO A PROLONGED HOSPITALIZATION. THE MEDICATION MILRINONE, AN INOTROPIC AGENT, WAS ADMINISTERED. ON (B)(6) 2022, THE PATIENT HAD AN ELECTROCARDIOGRAM (ECG) SHOWING AN ATRIOVENTRICULAR (AV) HEART BLOCK. THE PATIENT RECEIVED AN EXTERNAL ATRIAL PACEMAKER LEAD. ON (B)(6) 2022, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED SHOWING A NORMAL LVEF. THE PATIENT STATUS WAS STABLE.

  Patient problems: Heart Block; Heart Failure/Congestive Heart Failure

  MAUDE report 15365948 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 32 MM SJM RIGID SADDLE RING WAS IMPLANTED. POST PROCEDURE, THE PATIENT PRESENTED WITH JUNCTIONAL RHYTHM. NO MEDICAL INTERVENTION WAS PERFORMED. ON (B)(6) 2022, A SMALL RIGHT SIDED PNEUMOTHORAX WAS NOTED AND THE PATIENT RECEIVED 2 LITERS OF OXYGEN. THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND WAS PRESCRIBED ANTIBIOTICS. ON (B)(6) 2022, HYPOXEMIA AND PLEURAL EFFUSION WAS REPORTED AND REQUIRED A THORAX DRAIN TO BE PLACED. THE CAUSE OF THE HYPOXEMIA IS CAUSED BY PLEURAL EFFUSION DUE TO HEMATOMA OF THE RIGHT PLEURAL CAVITY. ON (B)(6) 2022, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND A VIDEO-ASSISTED THORACIC SURGERY (VATS) WAS PERFORMED. (B)(4).

  Patient problems: Arrhythmia; Hypoxia; Pleural Effusion; Pneumonia; Pneumothorax; Pulmonary Emphysema

  MAUDE report 13577405 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 32MM SJM RIGID SADDLE RING WAS IMPLANTED. POST IMPLANT PROCEDURE, JUNCTION RHYTHM WAS REPORTED. THE JUNCTION RHYTHM DID NOT LEAD TO PROLONGED HOSPITAL STAY. ON (B)(6) 2021, NUMBNESS OF LEFT FOOT WAS REPORTED. A NEUROLOGICAL EXAMINATION WAS PERFORMED AND NO ABNORMALITIES IN THE CRANIAL NERVES WERE NOTED. ON (B)(6) 2021, SINUS BRADYCARDIA WAS NOTED AFTER STARTING METOPROLOL AS WELL AS A MINIMAL PERIPHERAL PNEUMOTHORAX ON THE RIGHT WAS NOTED. NO TREATMENT WAS PERFORMED FOR PNEUMOTHORAX. THE PATIENT IS DOING WELL BUT IS STILL EXPERIENCING SINUS RHYTHM AND JUNCTIONAL RHYTHM. THE MITRAL VALVE PLASTY WAS A SUCCESS. (((B)(4)).

  Patient problems: Arrhythmia; Bradycardia; Pneumothorax

  MAUDE report 12843998 ↗
• 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 32MM SJM RIGID SADDLE RING WAS IMPLANTED. DURING PROCEDURE, THE PATIENT LOST A LOT OF BLOOD WHICH COULD HAVE LED TO ANIMA. THE PATIENT WAS RECEIVED 1 UNIT OF PACKED CELLS (PC). ON (B)(6) 2021, THE PATIENT PRESENTED WITH ARRHYTHMIA DUE TO THE RING BEING STITCHED NEAR THE AV NODE. RHYTHM DISORDERS ARE A COMMON COMPLICATIONS FOR THIS KIND OF PROCEDURE. A PERMANENT PACEMAKER WAS CONSIDERED BUT AT TIME HAS NOT BEEN IMPLANTED. THE RING WAS REPORTED TO BE PERFORMING AS INTENDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED. (CRD_985 - ARB PMCF; EU1671-309; ) (B)(4).

  Patient problems: Anemia; Arrhythmia

  MAUDE report 12548185 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 32MM SJM RIGID SADDLE RING WAS IMPLANTED. POST IMPLANT, DURING A ROUTINE CHEST X-RAY A PNEUMOTHORAX WAS NOTED. IT IS THOUGHT THAT THE PNEUMOTHORAX WAS CAUSED A THORAX DRAINAGE. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED.

  Patient problems: Pneumothorax

  MAUDE report 12518766 ↗