Rigid Saddle Ring RSAR-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067044716), received between Apr 14, 2023 and Jun 27, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Material Separation” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Adverse 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) 2022, A 32MM RIGID SADDLE RING WAS IMPLANTED. THE DAY AFTER DISCHARGE ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER THEY REPORTED NOT FEELING WELL, SUFFERING FROM "DEFECT OF MEMORY" AND HAD "FORGOTTEN ABOUT THINGS." A COMPUTED TOMOGRAPHY (CT) SCAN AND ULTRASOUND PERFORMED ON (B)(6) 2022 DID NOT REPORT ANY BLEEDING, STROKE, OR ANY OTHER FINDINGS. NO TREATMENT WAS REPORTED. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND DISCHARGED ON (B)(6) 2022 AFTER FEELING BETTER.

  Patient problems: Cognitive Changes

  MAUDE report 22345493 ↗
• InjuryMay 10, 2024Material Separation; Material Separation

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, A 32MM RIGID SADDLE RING WAS IMPLANTED FOR MITRAL VALVE REPAIR. IT WAS THEN REPORTED ON (B)(6) 2022, THE PATIENT WAS ADMITTED FOR HEART FAILURE. A TRANSTHORACIC ECHOCARDIOGRAPHY ON (B)(6) 2022 CONFIRMED SEVERE MITRAL REGURGITATION DUE TO ANNULOPLASTY DEVICE DEHISCENCE. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY ON (B)(6) 2022 ALSO CONFIRMED SEVERE MITRAL REGURGITATION. A DECISION WAS MADE TO SURGICALLY REMOVE THE 32MM RIGID SADDLE RING ON (B)(6) 2022 AND REPLACED WITH AN UNKNOWN DEVICE. THE PATIENT STATUS WAS REPORTED AS DISCHARGED ON (B)(6) 2023.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19288116 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON 05 SEPTEMBER 2022, A 32MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2022, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED DELIRIUM AND VISITED A CLINIC. THE PATIENT HAD A HEAD COMPUTED TOMOGRAPHY SCAN PERFORMED AND REVEALED MULTIPLE ISCHEMIC CARDIOEMBOLIC APOPLEX. THE DECISION WAS MADE TO HOSPITALIZE THE PATIENT.

  Patient problems: Embolism/Embolus; Stroke/CVA

  MAUDE report 18668186 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 32MM RIGID SADDLE RING WAS IMPLANTED DURING A MITRAL VALVE REPAIR. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS OR DEVICE DEFICIENCIES. ON (B)(6) 2022, THE PATIENT RETURNED DURING FOLLOW UP WITH COMPLAINTS OF DIFFICULTY BREATHING. THE PATIENT WAS DIAGNOSED WITH PLEURISY AND PRESCRIBED PARACETAMOL AND OXYCODON. THERE WERE NO DEVICE DEFICIENCIES REPORTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Inflammation

  MAUDE report 17740792 ↗
• InjuryAug 1, 2023Material Separation; Material Separation

  CLINICAL INFORMATION: CRD_985 - ARB PMCF PATIENT STUDY ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, A 32MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED. ON (B)(6) 2023, THE PATIENT WAS EXPERIENCED PARAPHASIA AND TEMPORARY PARAPLEGIA OF THE RIGHT ARM. THE PATIENT WAS ADMITTED WITH NEUROLOGICAL SYMPTOMS. ON (B)(6) 2023, A COMPUTERIZED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE IMAGING (MRI) THAT THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. APIXABAN WAS ADMINISTERED. IT WAS CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND SHOWED THAT THE SURGICAL SUTURE WAS LOOSENING. IT WAS BELIEVED THAT THE STROKE WAS CAUSED BY A THROMBUS ON THE SURGICAL SUTURE, BUT IMAGING OF THROMBUS WAS NOT CONFIRMED. SLIGHT APHASIA WAS STILL PRESENT AT THE TIME OF THE LAST REPORT. THE PATIENT WAS REPORTED AS STABLE AT HOME.

  Patient problems: Stroke/CVA

  MAUDE report 17437712 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF. DE4432 - (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023, A 32MM RIGID SADDLE RING WAS IMPLANTED IN A PATIENT. ON (B)(6) 2023, THE PATIENT RETURNED TO HOSPITAL AFTER PECTORAL SWELLING INDUCED BY SNEEZING. ECHOCARDIOGRAPHY SHOWED HEMATOMA IN REGION UNDER THE SURGICAL SCAR. THE PATIENT WAS TREATED WITH ANTICOAGULATION AND DID NOT REQUIRED A BLOOD TRANSFUSION. THE DEVICE CONTINUES TO WORK AS INTENDED.

  Patient problems: Hematoma

  MAUDE report 17135765 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_985 - ARB PMCF. PATIENT SITE ID:(B)(6). IT WAS REPORTED THAT ON (B)(6)2023, A 32MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED IN A PATIENT. PRIOR TO THE IMPLANT THE PATIENT HAD A NORMAL SINUS RHYTHM. THE 32MM RIGID SADDLE RING WAS SIZED USING A RING SIZER SET. THERE WAS NO DIFFICULTY EXPERIENCED IMPLANTING THE 32MM RIGID SADDLE RING. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS NOTED POST-IMPLANT, (B)(6) 2023, THAT THE PATIENT DEVELOPED A SECOND DEGREE ATRIOVENTRICULAR BLOCK. IT WAS NOTED THAT THE ATRIOVENTRICULAR BLOCK PROGRESSED TO A THIRD DEGREE ATRIOVENTRICULAR BLOCK WITHOUT RECOVERY. THE DECISION WAS MADE TO IMPLANT A PERMANENT PACEMAKER. THE PATENT WAS DISCHARGED AT THE TIME OF REPORT. THE ATRIOVENTRICULAR BLOCK IS ATTRIBUTED TO THE IMPLANT PROCEDURE. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE 32MM RIGID SADDLE RING OR PROCEDURE.

  Patient problems: Heart Block

  MAUDE report 16981997 ↗
• InjuryApr 14, 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) 2021, A 32MM RIGID SADDLE RING WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2021, THE PATIENT HAD AN ATRIAL FIBRILLATION. MEDICATION WAS ADMINISTERED. PATIENT HAD A PROLONGED HOSPITALIZATION TO MONITOR THE RHYTHM. ON (B)(6) 2021, THE PATIENT EXPERIENCED DELIRIUM. MEDICATION WAS ADMINISTERED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Atrial Fibrillation

  MAUDE report 16744324 ↗