SimuPlus™ 7700FB40 (UDI 00763000271350)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000271350), received between Aug 17, 2023 and Feb 11, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT AN ECHOCARDIOGRAM DISCOVERED MODERATE TO SEVERE MITRAL REGURGITATION. IT WAS ALSO NOTED THAT THE NATIVE MITRAL VALVE LEAFLETS WERE SCLEROTIC AND POTENTIALLY RHEUMATIC. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24318228 ↗
• InjuryJul 30, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS SEVERE MITRAL REGURGITATION, SEVERE PROLAPSE OF THE NATIVE POSTERIOR LEAFLET AND FLAIL POSTERIOR LEAFLET. IT WAS STATED THAT THE PATIENT EXPERIENCED RIGHT GROIN HEMATOMA, RIGHT PLEURAL EFFUSION REQUIRING RE-ADMISSION AND ADDITIONAL CHEST TUBE PLACEMENT VIA INTERVENTIONAL RADIOLOGY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Pleural Effusion

  MAUDE report 22667031 ↗
• InjurySep 20, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, A 34MM MITRAL ANNULOPLASTY BAND AND A 40MM MITRAL ANNULOPLASTY BAND WERE BOTH ATTEMPTED AND REPLACED WITH A 42MM MITRAL ANNULOPLASTY BAND OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE REGURGITATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20268693 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 40MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 42MM 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 18319105 ↗
• InjuryAug 17, 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 INFORMATION THAT DURING THE IMPLANT OF THIS 40MM 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17565218 ↗