HANCOCK® HC15016Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00681490908764), received between Aug 16, 2018 and Sep 13, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 8 MONTHS POST IMPLANT OF THIS 16MM PULMONARY BIOPROSTHETIC VALVE IMPLANTED IN A PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM PULMONARY BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12461067 ↗
• InjurySep 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 1 MONTH POST IMPLANT OF PART OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN THE AORTIC POSITION OF A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 21MM BIOPROSTHETIC AORTIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12422505 ↗
• InjuryOct 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 7 MONTHS POST IMPLANT OF THIS 16 MM PULMONARY VALVED CONDUIT IN A (B)(6) MONTHS 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: No Information

  MAUDE report 10647870 ↗
• InjuryAug 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 11 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10401070 ↗
• InjuryJun 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS AND 15 DAYS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH AN 18MM PULMONARY VALVED CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10153424 ↗
• InjurySep 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS 1 MONTH POST IMPLANT OF THIS 16MM BIOPROSTHETIC VALVED CONDUIT IN THE PULMONARY POSITION OF A (B)(6) YEAR-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 25MM VALVED CONDUIT OF THE SAME MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8976637 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 11 MONTHS POST IMPLANT OF THIS 16MM BIOPROSTHETIC PULMONARY VALVED CONDUIT IMPLANTED IN THIS PEDIATRIC PATIENT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH AN 18MM TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Congenital Defect/Deformity; No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 8556143 ↗
• InjuryMar 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT NINE YEARS AND TEN MONTHS POST IMPLANT OF THIS 16MM BIOPROSTHETIC PULMONARY VALVED CONDUIT IMPLANTED IN A (B)(6) PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM CONDUIT OF THE SAME MODEL. THE CONDUIT WAS REPLACED DUE TO SEVERE STENOSIS AND SUPRASYSTEMIC RIGHT VENTRICULAR PRESSURE. OF NOTE, A "CUFF" OF THE PROXIMAL AND DISTAL PORTIONS OF THE ORIGINAL GRAFT WAS RETAINED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis; Right Ventricular Dysfunction

  MAUDE report 8391813 ↗
• InjuryOct 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 5 YEARS POST IMPLANT OF THIS 16 MM PULMONARY VALVED CONDUIT IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 23 MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Information; Pulmonary Valve Stenosis

  MAUDE report 7985562 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN AN 18 MONTH OLD PEDIATRIC PATIENT, AN 18MM 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

  MAUDE report 7789388 ↗