Tri-Ad™ 900SFC230Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000102326), received between Aug 5, 2021 and Jul 29, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Patient Device Interaction Problem

  It was reported that 7 days post implant of this 30mm tricuspid annuloplasty band, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as sick sinus syndrome (SSS) and atrial arrythmias (atrial tachycardia (AT), atrial fibrillation (AF) and atrial flutter (A-Fl). No additional adverse patient effects were reported.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Tachycardia

  MAUDE report 50065971 ↗
• InjuryMar 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 DAYS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM (EKG) SHOWED ATRIAL FIBRILLA TION. IT WAS REPORTED THAT 5 DAYS LATER, ON (B)(6) 2025, THE PATIENT UNDERWENT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND CARDIOVERSION AND CONVERTED TO NORMAL SINUS RHYTHM WITH 1ST DEGREE BLOCK. IT WAS ALSO REPORTED THAT THE PATIENT WAS TEMPORARILY RECEIVING ANTIARRHYTHMIC MEDICATIONS. IT WAS FURTHER NOTED THAT THE PATIENT WAS DISCHARGED WITH A HOME CARDIAC EVENT MONITOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 24519926 ↗
• InjuryMar 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 DAYS POST IMPLANT OF THIS OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM SHOWED THAT THE PATIENT DEVELOPED COMPLETE HEART BLOCK (CHB). SUBSEQUENTLY IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT SUCCESSFULLY HAD A DUAL CHAMBER LEADLESS PERMANENT PACEMAKER IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24512181 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED IN THE SAME POSITION WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24176809 ↗
• InjuryNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY HEART BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MI TRAL BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23664759 ↗
• InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 10 MONTHS POST IMPLANT OF THESE TRI-AD AND SIMULUS HEART BANDS, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASONS FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA, SICK SINUS SYNDROME (SSS), ATRIAL FIBRILLATION, ATRIAL FLUTTER AND ATRIAL TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Bradycardia; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 23083555 ↗
• InjuryJan 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT RE CONVERTED TO ATRIAL FIBRILLATION AND WAS TREATED WITH A BOLUS OF ANTIARRHYTHMIC MEDICATION AND LATER CONVERTED TO NORMAL SINUS RHYTHM. IT WAS STATED THAT THE PATIENT DEVELOPED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE DURING THE INDUCTION PERIOD OF THE IMPLA NT PROCEDURE, BUT PRIOR TO IMPLANT OF THE BAND. THE PATIENT WAS THEN TREATED WITH A BOLUS OF ANTIARRHYTHMIC MEDICATION AND CARDIOVERTED TWICE, RETURNING TO SINUS RHYTHM. IT WAS NOTED THAT THE SURGEON DECIDED TO PERFORM A MAZE PROCEDURE DURING THE OPERATION. IT WAS STATED THAT DUE TO THE WORSENING OF THE PATIENTS ATRIAL FIBRILLATION POST-OPERATIVELY, THE PATIENT REQUIRED MEDICAL INTERVENTION, QUALIFYING THIS EVENT AS DEVICE-RELATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 21195965 ↗
• InjuryDec 3, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS MODERATE TO SEVERE TRICUSPID REGURGITATION. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF CHEST PAIN, DYSPNEA AND SYNCOPE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain; Dyspnea; Insufficient Information; Syncope/Fainting; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 20834697 ↗
• InjuryJun 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS RESIDUAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 19558056 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PHYSICIAN FELT THE PATIENT'S NATIVE TRICUSPID VALVE COULD BE REPAIRED USING THIS 30MM TRICUSPID ANNULOPLASTY BAND. IT WAS REPORTED THAT POST REPAIR, THE TRICUSPID VALVE STILL DEMONSTRATED SEVERE TRICUSPID REGURGITATION. THE 30MM TRICUSPID ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A 31MM NON-MEDTRONIC BIOPROSTHETIC VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 17022417 ↗
• InjuryApr 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 28MM BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 16775606 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIO-VENTRICULAR BLOCK (AVB). THE PATIENT HAS NOW RECOVERED/RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 16644146 ↗
• InjuryDec 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 DAYS POST IMPLANT OF THIS 27MM TRICUSPID ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO NON-HEMORRHAGIC PERICARDIAL EFFUSION. IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) PERFORMED NOTED PERICARDIAL EFFUSION AND INDICATED THE NEED FOR A SURGICAL INTERVENTION OF RE-STERNOTOMY. A DIAGNOSTIC BLOOD TEST PERFORMED NOTED BLEEDING AND ANEMIA. IT WAS REPORTED THAT DURING THE SURGICAL INTERVENTION, 300ML OF EFFUSION FLUID WAS DRAINED AND HEMATOMA EVACUATION TOOK PLACE. IT WAS STATED THAT PRIOR TO SURGICAL INTERVENTION, THE PATIENT EXPERIENCED PAIN DUE TO SWELLING AND MODERATE RECURRENT PERICARDIAL EFFUSION. THE EVENT HAS RESOLVED AND THE PATIENT RECOVERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 15981730 ↗
• InjuryAug 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 12280007 ↗