SJM™ RSAR-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734009423), received between Jun 11, 2021 and Nov 3, 2022 — classified as 1 death, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathNov 3, 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: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 26MM RIGID RING SADDLE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE 29MM RIGID RING SADDLE WAS SIZED USING A RING SIZER SET. THAT SAME DAY THE PATIENT HAD A TRICUSPID ANNULOPLASTY PERFORMED. ON (B)(6) 2021, THE PATIENT SUFFERED AN ISCHEMIC STROKE AND WAS ADMITTED TO THE HOSPITAL. THE ISCHEMIC STROKE IS BELIEVED TO HAVE BEEN CAUSED BY A MICROEMBOLI THAT FORMED DURING OR AFTER PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD BEEN PRESCRIBED ANTICOAGULANTS AFTER THE IMPLANT PROCEDURE. ON (B)(6) 2021, A MAGNETIC RESONANCE IMAGING EXAM WAS PERFORMED AND DISCOVERED NEW GANGLION INFARCTS IN THE PATIENT'S BRAIN. A COMPUTED TOMOGRAPHY SCAN WAS ALSO PERFORMED AND DISCOVERED MASSIVE INTRACRANIAL HEMORRHAGING AS A RESULT OF THE ISCHEMIC STROKE. THE PATIENT HAD A CRANIOTOMY PERFORMED AND REQUIRED A TRANSFUSION. AFTER THE CRANIOTOMY IT WAS NOTED THAT THE PATIENT HAD HIGH BRAIN PRESSURE. THE PATIENT DIED ON (B)(6) 2022, DUE TO MASSIVE INTERCRANIAL BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 15721393 ↗
• InjuryOct 3, 2022Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2022, A 26MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE RING HAD BEEN SIZED USING A RING SIZER SET. HOWEVER, POST-IMPLANT, THERE WAS SEVERE MITRAL REGURGITATION (MR) CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM EXAMINATION. THE PATIENT HAD BEEN TAKEN OFF BYPASS TO CHECK EFFECTIVENESS OF THE RING, BUT WAS PLACED BACK ON BYPASS AFTER CONFIRMING SEVERE MR. THE RING WAS EXPLANTED AND REPLACED INTRAOPERATIVELY WITH A 25MM SJM MASTERS SERIES VALVE WITH EXPANDED CUFF TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AND RECOVERING AT THE TIME OF REPORT. THE CAUSE FOR THE SEVERE MITRAL REGURGITATION IS UNKNOWN.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15533879 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A 26MM SJM RIGID SADDLE RING WAS CHOSEN FOR TREATMENT FOR MITRAL VALVE PROLAPSE WITH SEVERE MITRAL VALVE REGURGITATION. DURING THE PROCEDURE THE USER PERFORMED A TRIANGULAR RESECTION AND ANNULOPLASTY. THE DEVICE WAS PLACED AND APPEARED TO BE SATISFACTORY, HOWEVER, POST CARDIOPULMONARY BYPASS, A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED REVEALING PERSISTENT AND MODERATE MITRAL REGURGITATION. THERE WAS NO STRUCTURAL DAMAGE TO THE RING. THE CAUSE FOR PERSISTENT REGURGITATION MAY HAVE BEEN RELATED TO SOMETHING OTHER THAN THE RING ITSELF. UNDETECTED AML PROLAPSE WAS DISCOVERED SO IT WAS DETERMINED THAT THE ISSUE WAS ALSO ASSOCIATED TO THIS AND COULD BE THE REASON FOR RESIDUAL MITRAL REGURGITATION. A MAJOR COMPONENT LEADING TO THE PATIENTS MITRAL REGURGITATION (MR) WAS POSTERIOR MITRAL LEAFLET (PML) PROLAPSE. THERE WAS AN IMPROVEMENT AFTER THE VALVE REPAIR AND THE MR IMPROVED FROM BEING SEVERE TO MODERATE BUT THE LEVEL OF RESIDUAL MR WAS UNACCEPTABLE, THEREFORE THE PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS (CPB) AND UNDERWENT A MITRAL VALVE REPLACEMENT (MVR). THE DEVICE WAS EXPLANTED AND EXCHANGED FOR A NEW MITRAL VALVE, A NON- ABBOTT DEVICE. THE EVENT DID LEAD

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 13757923 ↗
• InjuryJan 6, 2022Backflow; Backflow

  IT WAS REPORTED THAT ON (B)(6) 2021, THAT A 26 MM SJM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED FOR A MITRAL VALVE REPAIR. AFTER THE SURGERY, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED NO MITRAL REGURGITATION (MR). ON (B)(6) 2021, 2D ECHO SHOWED THAT THERE WAS SEVERE MR. THE DEVICE WAS EXPLANTED AND REPLACED WITH A 27 MM SJM MASTERS SERIES VALVE EXPANDED CUFF TO RESOLVE THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Rupture

  MAUDE report 13176435 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 26 MM SJM RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2021, A CHEST CT SHOWED A HEMOTHORAX ON THE RIGHT SIDE. THE HEMOTHORAX WAS SURGICALLY REMOVED. IT IS UNKNOWN WHAT CAUSED IT. THERE WERE NO COMPLICATIONS DURING THE IMPLANT PROCEDURE ON (B)(6) 2021. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SINCE HAS BEEN DISCHARGED.

  Patient problems: Hemothorax

  MAUDE report 11982209 ↗