SimuPlus™ 7700FB28 (UDI 00763000270995)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000270995), received between Nov 10, 2020 and Feb 1, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT THE PATIENT DEVELOPED RIGHT SIDED WEAKNESS, APHASIA AND RIGHT FACIAL DROP. IT WAS STATED THAT THE PATIENT UNDERWENT COMPUTED TOMOGRAPHY IMAGING WHICH REVEALED A LEFT SUPERIOR FRONTAL LOBE STROKE, LEFT VENOUS SINUS THROMBOSIS AND CHRONIC LEFT VERTEBRAL OCCLUSION. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED NOTED THICKENED AND FOCALLY CALCIFIED NATIVE MITRAL VALVE LEAFLETS AND THERE WAS A CALCIFIED SEGMENT OF THE POSTERIOR LEAFLET WHICH APPEARS TO FLAIL. THE PATIENT RECEIVED "INTERMITTENT PRESSOR THERAPY TO MEET MAP REQUIREMENT" RELATED TO CEREBRAL VASCULAR ACCIDENT (CVA) AND ANTIBIOTIC MEDICATIONS WERE GIVEN. IT WAS REPORTED THAT THE PATIENTS LEFT TOE APPEARED NECROTIC AND A LEFT LOWER EXTREMITY ANGIOGRAPHY PERFORMED 8 DAYS LATER NOTED LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) STENOSIS WITH DIFFUSE DISEASE AND AN OCCLUSION IN THE MID SFA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Muscle Weakness/Atrophy; Obstruction/Occlusion; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 18627355 ↗
• InjuryJul 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE. THE SURGEON STATED THAT THEY ATTEMPTED A REPAIR USING THE BAND, HOWEVER THE PATIENT HAD DIFFICULT ANATOMY AND REPAIR WAS NOT POSSIBLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12099511 ↗
• InjuryNov 10, 2020Improper Flow or Infusion; Insufficient Device Problem Information; Improper Flow or Infusion; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 32MM 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; No Information

  MAUDE report 10818371 ↗