NA H607M63 (UDI 10681490268551)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10681490268551), received between Jul 1, 2022 and Jan 2, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 11 MONTHS POST IMPLANT OF THIS 63MM TRICUSPID POSTERIOR ANNULOPLASTY BAND, A DEFIBRI LLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CONGESTIVE HEART FAILURE, ISCHEMIC CARDIOMYOPATHY AND END OF LIFE FOR THE DEFIBRILLATOR, NECESSITATING THE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Heart Failure/Congestive Heart Failure

  MAUDE report 21059909 ↗
• InjuryJan 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 2 MONTHS POST IMPLANT OF THIS 63MM TRICUSPID POSTERIOR ANNULOPLASTY BAND, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS ISCHEMIC CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 21058622 ↗
• InjuryAug 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH INDICATED THAT THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS CHRONIC SYSTOLIC CONGESTIVE HEART FAILURE (CHF) AND ISCHEMIC CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Heart Failure/Congestive Heart Failure; Non specific EKG/ECG Changes

  MAUDE report 20025421 ↗
• InjuryAug 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 24 YEARS AND 9 MONTHS POST IMPLANT OF THIS 63MM POSTERIOR ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADY/TACHY SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19936930 ↗
• InjuryMar 14, 2024Insufficient 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 ANOTHER BAND 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 18907115 ↗
• MalfunctionJan 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  MEDTRONIC RECEIVED INFORMATION THAT THIS 63MM ANNULOPLASTY BAND WAS IMPLANTED 7 YEARS AND 10 MONTHS BEYOND ITS USE-BY DATE. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574284 ↗
• InjuryJul 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 63MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED 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; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 14884095 ↗