SJM™ SARP-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734007528), received between Sep 26, 2018 and Jan 3, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON 12 DECEMBER 2023, A 32MM SEGIUN MITRAL VALVE RING WAS CHOSEN FOR IMPLANTATION. AFTER IMPLANTATION, IT WAS FOUND BY INTRAOPERATIVE ULTRASOUND THAT THERE WAS STILL MODERATE MITRAL REGURGITATION. THE SEGIUN RING WAS REMOVED AND A MITRAL VALVE REPLACEMENT PROCEDURE WAS PERFORMED. THE OPERATION WAS EXTENDED BY 30 MINUTES, BUT THERE WAS NO PATIENT EFFECTS DUE TO THE DELAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439957 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SEGUIN ANNULOPLASTY RING, 32MM WAS IMPLANTED ON (B)(6) 2022. PRIIT WAS REPORTED THAT A 32MM SEGUIN ANNULOPLASTY RING WAS IMPLANTED ON (B)(6) 2022. PRIOR TO IMPLANT THE PATIENT HEMOGLOBIN WAS HB: 8.2MMOL/L ((B)(6) 2022), THROMBOZYTEN: 201 ((B)(6) 2022). POST PROCEDURE, ROTEM TEST SHOWED DECREASE ANEMIA WITH A HEMOGLOBIN OF 4.4MG/DL. PATIENT WAS TREATED WITH FIBRINOGEN, PROTHROMBIN-PROCONVERTIN-STUART FACTOR-ANTIHEMOPHILIC FACTOR B, AND WAS TRANSFUSED ONE UNIT OF RED BLOOD CELL. THE PATIENT WAS REPORTED TO BE STABLE AND WAITING FOR REHAB.

  Patient problems: Anemia

  MAUDE report 15059544 ↗
• InjuryApr 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM SEMI-RIGID SADDLE RING(B)(4) WAS IMPLANTED IN THE MITRAL POSITION. AFTER THE RING WAS IMPLANTED AND DURING THE SALINE TEST, IT WAS OBSERVED THAT THERE WAS IMPROPER COAPTATION. THE USER ALLEGED THAT THIS FAILURE WAS DUE TO THE SEVERE CALCIFICATION OF THE ANNULUS AND PATIENT ANATOMY. IT WAS NOTED THAT THERE WERE NO ALLEGATIONS OF MALFUNCTION AGAINST THE SEMI-RIGID SADDLE RING. THE RING WAS REPLACED WITH A 32MM SEMI-RIGID SADDLE RING (B)(4) INTRAOPERATIVELY. ON (B)(6) 2022, THE 32MM RING WAS EXPLANTED SINCE THERE WAS NOT MUCH IMPROVEMENT WITH RESPECT TO REGURGITATION. THE PATIENT WAS SUFFERING FROM DYSPNEA AFTER COMING OFF FROM VENTILATION SUPPORT IN THE INTENSIVE CARE UNIT (ICU). THE USER ALLEGED THAT THIS FAILURE WAS ALSO DUE TO SEVERE CALCIFICATION OF THE ANNULUS AND PATIENT ANATOMY AS WELL. THERE WERE NO ALLEGATIONS OF MALFUNCTION AGAINST THE SADDLE RING. IT WAS NOTED THAT DURING THE PROCEDURE, THEY HAD NO OTHER SUITABLE SIZED RING AVAILABLE SO THEY USED THE 32MM SEMI-RIGID SADDLE RING. THE DEVICE WAS REPLACED WITH A NON-ABBOTT MECHANICAL VALVE. IT WAS NOTED THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT BOTH PROCEDURES. THE

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 14081828 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 32MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE, THE PATIENT HAD 2 SEIZURES AND WAS TREATED WITH MIDAZOLAM. THE CAUSE IS UNKNOWN. ON (B)(6) 2022, INCREASED CREATININE LEVELS WERE NOTED AND THE PATIENT WAS TREATED WITH TORASEMID. INCREASED CREATINE LEVELS IS A PRE-EXISTING CONDITION AND WAS WORSENED DUE THE PROCEDURE. ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING DELIRIOUS SYMPTOMS AND WAS TREATED WITH HALOPERIDOL HOWEVER, THE CAUSE IS UNKNOWN. THERE WERE NO COMPLICATIONS NOTED DURING THE IMPLANT PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. CRD_985 - ARB PMCF; DE4019-173; R651211401, R651213701, R651213101.

  Patient problems: Confusion/ Disorientation; Convulsion/Seizure; Renal Failure

  MAUDE report 13440190 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 32MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. AFTER THE RING WAS IMPLANTED BUT STILL DURING THE PROCEDURE, ABNORMAL FIBRINOGEN LEVEL WAS NOTED AND THE PATIENT WAS ADMINISTRATED IV MEDICATION. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED RECURRENT VENTRICULAR FIBRILLATION DUE TO A PACEMAKER PROBE AND THE PATIENT WAS CARDIOVERTED. THE PATIENT IS STILL IN THE HOSPITAL AND REPORTED TO BE IN STABLE CONDITION. ((B)(4)).

  Patient problems: Coagulation Disorder; Ventricular Fibrillation

  MAUDE report 13391847 ↗
• 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 32MM SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING WAS IMPLANTED. POST PROCEDURE, THE PATIENT RECIEVED 4 UNITS OF FRESH FROZEN PLASMA (FFP) INTRAVENOUSLY. THE REASON IS UNKNOWN. THE PATIENT DOES HAVE A HISTORY OF ANEMIA. ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING COGNITIVE DYSFUNCTION AND WAS ADMINISTRATED MEDICATION. THE PATIENT IS STILL IN THE HOSPITAL AND REHABILITATION IS BEING DISCUSSED. THERE WERE NO COMPLICATIONS NOTED DURING IMPLANT PROCEDURE. (B)(4).

  Patient problems: Anemia; Cognitive Changes

  MAUDE report 12858260 ↗
• InjurySep 26, 2018Expiration Date Error; Expiration Date Error

  ON (B)(6) 2018, A 32 MM SEMI-RIGID ANNULOPLASTY RING (SARP) WAS SELECTED FOR A MITRAL REPAIR AFTER A QUADRANGULAR P2 RESECTION. THE SARP RINGS HAD BEEN SCATTERED ON THE BACK TABLE SEARCHING FOR THE CORRECT SIZE. THE CIRCULATOR HANDED THE RING TO THE PHYSICIAN WITHOUT VERIFYING THE EXPIRATION DATE. THE PHYSICIAN SUTURED IN THE RING AND AS THE PROCEDURE WAS BEING COMPLETED, AN OPERATING ROOM STAFF MEMBER IDENTIFIED THE DEVICE HAD AN EXPIRATION DATE OF (B)(6) 2018. THE PHYSICIAN ELECTED TO LEAVE THE DEVICE IMPLANTED AND CLOSED THE PATIENT'S CHEST. POST-OPERATIVELY, THE PATIENT WAS REPORTED TO BE STABLE. THE PATIENT WAS NOTIFIED ABOUT THE DEVICE EXPIRATION, AND NO ADDITIONAL PRECAUTIONS HAVE BEEN TAKEN. THE PATIENT HAS SINCE BEEN DISCHARGED ON ANTIBIOTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7913075 ↗