SimuPlus™ 7700FB42 (UDI 00763000271367)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000271367), received between Jul 11, 2022 and Apr 2, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24765759 ↗
• InjuryMar 25, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITIONS/ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24684912 ↗
• InjuryDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 42MM 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

  MAUDE report 23863782 ↗
• InjuryFeb 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 42MM SIMUPLUS MITRAL BAND, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21469628 ↗
• InjuryFeb 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY BAND AND 42MM MITRAL ANNULOPLASTY BAND, AN ELECTROCARDIOGRAM (EKG) DISCOVERED ATRIAL TACHYCARDIA WITH A 2 - 1 ATRIOVENTRICULAR (AV) CONDUCTION. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL, AND 1 DAY LATER, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CARDIOVERSION WAS PERFORMED. THE REASON FOR THE INTERVENTION WAS DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21293538 ↗
• InjuryOct 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT INDICATED THAT ON THE SAME DAY POST IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS "HEATBEAT IRREGULARITY." NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20406375 ↗
• InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND AND 28MM TRICUSPID ANNULOPLASTY BAND, THE PATIENT HAD JUNCTIONAL RHYTHM, COMPLETE HEART BLOCK, AND ATRIAL FLUTTER. IT WAS STATED THAT ALL ATRIO-VENTRICULAR (AV) NODAL BLOCKING AGENTS WERE HELD. 3 DAYS LATER, THE PATIENT CONVERTED TO NORMAL SINUS RHYTHM UNTIL DISCHARGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Flutter; Heart Block

  MAUDE report 19632075 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND, THE PATIENT HAD AN ELECTROCARDIOGRAM (ECG) PERFORMED WHICH INDICATED JUNCTIONAL RHYTHM. IT WAS REPORTED THAT MEDICATIONS WERE GIVEN AND THE EVENT RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18905599 ↗
• InjuryMay 24, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 42MM MITRAL 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

  MAUDE report 16998040 ↗
• InjuryJul 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 42MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 42MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14977146 ↗