HANCOCK® HC15022Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00681490908818), received between Jul 7, 2017 and Apr 3, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 22MM HANCOCK VALVE CONDUIT, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SICK SINUS SYNDROME (SSS) AND PRIMARY PREVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24775844 ↗
• InjuryJan 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 22 YEARS AND 5 MONTHS POST IMPLANT OF THIS 22MM VALVED CONDUIT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21124682 ↗
• InjuryJan 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 11 MONTHS POST IMPLANT POST IMPLANT OF THIS 22MM VALVED CONDUIT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 21124515 ↗
• InjuryOct 30, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 1 MONTH POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 13 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS AND MODERATE PULMONARY REGURGITATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD A COVERED STENT IMPLANTED PRIOR TO VALVE IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 20570879 ↗
• InjuryDec 8, 2023Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 12 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS PULMONARY STENOSIS, SEVERE PULMONARY REGURGITATION AND A HIGH GRADIENT GREATER THAN 35MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 18291483 ↗
• InjuryAug 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE PULMONARY INSUFFICIENCY AND PULMONARY STENOSIS DUE TO SOMATIC OUTGROWTH OF THE ORIGINAL CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 17600021 ↗
• InjuryMay 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 3 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 8 YEAR OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16863680 ↗
• InjuryMar 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT REPORTED THE REASON FOR REPLACEMENT AS THERE WAS AN OBSTRUCTION IN THE CONDUIT DUE TO PULMONARY STENOSIS AND "SUPRAVALVULAR MEMBRANE". IT WAS ALSO MENTIONED THAT TRIVIAL REGURGITATION WAS ALSO PRESENT. IT WAS STATED THAT THE PATIENT DOES NOT HAVE ANY CONDITION OR IS ON ANY MEDICATION THAT COULD BE CONTRIBUTING TO THE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Obstruction/Occlusion; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 16626104 ↗
• InjuryNov 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 9 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15852314 ↗
• InjuryJul 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 16 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 15086680 ↗
• InjuryNov 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 1 MONTH POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12815424 ↗
• InjuryAug 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 1 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 12293083 ↗
• InjuryJan 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 18 YEARS AND 6 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 11116834 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN AN (B)(6)-YEAR-OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE CONDUIT WAS REPLACED DUE TO MODERATE-TO-SEVERE STENOSIS AND MODERATE-TO-SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis; Respiratory Insufficiency

  MAUDE report 10729281 ↗
• InjuryAug 13, 2020Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 1 MONTH POST IMPLANT OF THIS BIOPROSTHETIC PULMONARY VALVED CONDUIT IMPLANTED IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE. IT WAS REPORTED THAT THE CONDUIT WAS REPLACED DUE TO PROGRESSIVE SEVERE STENOSIS WITH INCREASED GRADIENTS OF 80MMHG. DURING THE PROCEDURE SUPRA-SYSTEMIC PULMONARY ARTERY PRESSURE WITH A 45MMHG PULMONARY VALVE GRADIENT WAS NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 10402932 ↗
• InjuryApr 16, 2020Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 7 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE DEPLOYED TO 22MM. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 9968799 ↗
• InjuryApr 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 3 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IMPLANTED IN AN APPROXIMATELY (B)(6) YEAR OLD PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 9961080 ↗
• InjuryApr 2, 2020Gradient Increase; Obstruction of Flow; Gradient Increase; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 6 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, THERE WAS MILD PULMONARY INSUFFICIENCY, HOWEVER THE LEAFLETS WERE FUNCTIONING APPROPRIATELY. THE 22MM CONDUIT WAS MEASURED TO BE 19MM WITH A SUBVALVAR OBSTRUCTION WHICH WAS THOUGHT TO BE A MUSCLE BUNDLE. THE PHYSICIAN THOUGHT THAT SINCE THERE WAS A COMPLEX LESION, DISTAL TO THE CONDUIT, PRIMARY INTERVENTION WAS NECESSARY, AND SEVERAL BALLOON DILATIONS OF THE LPA WERE PERFORMED, WHICH RELIEVED THE GRADIENT, HOWEVER AFTER 8 HOURS OF COMPLEX INTERVENTION, THE DECISION WAS MADE TO DELAY CONDUIT INTERVENTION SINCE THE GRADIENT DECREASED TO AROUND 25MMHG, AND THE CONDUIT REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Insufficiency

  MAUDE report 9916784 ↗
• InjuryDec 17, 2019Gradient Increase; Incomplete Coaptation; Gradient Increase; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 9 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC PULMONARY VALVED CONDUIT IMPLANTED IN AN (B)(6) PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED TO BE HIGH RESTING GRADIENTS, STENOSIS, DYSFUNCTION FROM THICKENED VALVE LEAFLETS, AND MILD REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 9481424 ↗
• InjuryApr 26, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 1 MONTH POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY VALVE (TPV) DUE TO STENOSIS AND INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 8556012 ↗
• InjuryAug 2, 2018Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND TEN MONTHS POST IMPLANT OF THIS VALVED CONDUIT IN THE PULMONARY POSITION, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO MODERATE REGURGITATION AND STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Regurgitation; Pulmonary Valve Stenosis; Regurgitation; Stenosis

  MAUDE report 7743777 ↗
• InjuryJun 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 1 MONTH POST IMPLANT OF THIS 22MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7609769 ↗
• InjuryJul 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FIFTEEN YEARS POST-IMPLANT OF THIS BIOPROSTHETIC PULMONIC VALVE IN A PEDIATRIC PATIENT, THIS DEVICE WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6693065 ↗