Hancock™ HC15025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169646612), received between Aug 16, 2019 and Sep 15, 2025 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjurySep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 2 MONTHS POST IMPLANT OF THIS HANCOCK VALVED CONDUIT, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23049292 ↗
• InjuryNov 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 16 YEARS, 11 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM PULMONARY VALVED CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20663204 ↗
• InjuryJun 10, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 12 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME MODEL. AND SIZE THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Stenosis

  MAUDE report 19505513 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE SURGERY TO IMPLANT THIS 25MM PULMONARY VALVED CONDUIT, BLEEDING WAS NOTED ON THE SUTURE LINES. THE PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS (CPB) AND THE SUTURE LINES WERE REINFORCED. AFTER REMOVAL FROM CPB, BLEEDING WAS PRESENT AGAIN. CPB WAS RE-INITIATED AND THE AREAS WERE REINFORCED WITH MORE SUTURES. THEN, THE PATIENT WEANED FROM CPB WITHOUT DIFFICULTY AND WITHOUT SIGNIFICANT RESIDUAL BLEEDING. AT THE CONCLUSION OF THE PROCEDURE, ATRIAL FIBRILLATION (AFIB) AND ATRIAL FLUTTER WERE PRESENT. THE PATIENT WAS SUCCESSFULLY CARDIOVERTED AND SENT TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. IN THE IMMEDIATE POST OPERATIVE PERIOD THE PATIENT DEVELOPED "BRISK, SANGUINEOUS" OUTPUT FROM THE MEDIASTINAL AND PLEURAL DRAINS. THE PATIENT WAS HYPOTENSIVE. ATRIAL FLUTTER OCCURRED AGAIN, AND THE PATIENT WAS UNABLE TO BE PACED WITH THE TEMPORARY PACING WIRES,BUT SPONTANEOUSLY CORRECTED TO NORMAL SINUS RHYTHM. A SECOND ATRIAL FLUTTER EPISODE WAS SUCCESSFULLY TREATED WITH EXTERNAL PACING. A THIRD ARRHYTHMIA EPISODE HOWEVER REQUIRED 1 MINUTE OF CARDIOPULMONARY RESUSCITATION (CPR), EPINEPHRINE AND DEFIBRILLATION. AT THAT TIME THE PATIENT

  Patient problems: Atrial Fibrillation; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Hemothorax; Pleural Effusion

  MAUDE report 11351371 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 DAYS POST IMPLANT OF THIS 25MM BIOPROSTHETIC VALVE IN THE PULMONARY POSITION OF A PEDIATRIC PATIENT, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8901424 ↗