HANCOCK® HC15025Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00681490908832), received between Jul 17, 2017 and Nov 19, 2025 — classified as 25 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVE CONDUIT, IN A THEN 14 YEAR OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS STENOSIS, SEVERE PULMONARY INSUFFICIENCY AND HIGH GRADIENT (31MMHG). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23592790 ↗
• InjuryOct 21, 2024Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE PULMONARY REGURGITATION (AR), PULMONARY STENOSIS (AS) AND A GRADIENT OF 25MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20491762 ↗
• InjuryJul 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 15 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

  MAUDE report 19803754 ↗
• InjuryJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 14 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 19615747 ↗
• InjuryJun 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 9 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

  MAUDE report 19578907 ↗
• InjuryApr 19, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 22 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE PULMONARY STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 19145074 ↗
• InjuryFeb 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 20 YEAR OLD 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 18676804 ↗
• InjuryDec 15, 2023Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 13 YEAR OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 18335355 ↗
• InjuryNov 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IN A 10 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

  MAUDE report 15784464 ↗
• InjuryOct 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 20 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IN A 11 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 SEVERE PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 15600739 ↗
• InjuryJul 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A DEVICE 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 12188604 ↗
• InjuryJun 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IN AN (B)(6) PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 12008978 ↗
• InjuryMay 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME SIZE AND MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11765586 ↗
• InjuryMar 8, 2021Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 25 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS WITH A 33MMHG GRADIENT AND MODERATE TO SEVERE PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 11436144 ↗
• InjuryFeb 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 22 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM 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: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 11302212 ↗
• InjuryFeb 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC MITRAL VALVE IMPLANTED IN THE PULMONARY POSITION. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11265686 ↗
• InjuryJul 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 5 MONTHS POST IMPLANT, A 25MM PULMONARY VALVED CONDUIT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE PULMONARY STENOSIS AND MODERATE PULMONARY INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 10304880 ↗
• InjuryApr 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 2 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 9961086 ↗
• InjuryMay 20, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 26 YEARS 4 MONTHS POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, IT WAS REPLACED VALVE-IN-VALVE WITH AN 18MM TRANSCATHETER PULMONARY VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 8624346 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 9 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME SIZE AND MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8558008 ↗
• InjuryApr 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 25MM PULMONARY VALVED CONDUIT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME SIZE AND MODEL.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8516347 ↗
• InjuryJul 30, 2018Gradient Increase; Insufficient Device Problem Information; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 11 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7732277 ↗
• InjuryJun 28, 2018Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS AND ELEVATED GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 7648691 ↗
• InjuryJan 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS BIOPROSTHETIC VALVED CONDUIT, THE VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7231609 ↗
• InjuryJul 17, 2017Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT NINE YEARS, SIX MONTHS POST IMPLANT OF THIS BIOPROSTHETIC PULMONIC VALVE, THIS DEVICE WAS EXPLANTED AND REPLACED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Valve Stenosis

  MAUDE report 6716961 ↗