HANCOCK® HC105-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00681490908641), received between Sep 27, 2019 and Sep 5, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

1 other recall cover devices cleared under the same FDA submission (P870078); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS MYOCARDIAL INFARCTION (MI) AND VENTRICULAR TACHYCARDIA (VT). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Myocardial Infarction; Tachycardia

  MAUDE report 17683801 ↗
• InjuryAug 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 20 YEARS AND 1 MONTH POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT, 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 17660958 ↗
• InjuryJun 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 5 MONTHS POST IMPLANT OF THIS 22MM PULMONARY BIOPROSTHETIC VALVE, A 18MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 14652632 ↗
• InjuryMay 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 8 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 3 YEARS 8 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: Insufficient Information

  MAUDE report 14365788 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED TO BE DUE TO VENTRICULAR TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 14250418 ↗
• InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A (B)(6) 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; Pulmonary Valve Stenosis

  MAUDE report 14017328 ↗
• InjurySep 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 10 MONTHS 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: Fatigue; No Information; Pulmonary Regurgitation

  MAUDE report 10579584 ↗
• InjurySep 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 7 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, A BALLOON ANGIOPLASTY WAS PERFORMED DUE TO MILD TO MODERATE CONDUIT STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 10549985 ↗
• InjuryJun 19, 2020Fracture; Gradient Increase; Insufficient Device Problem Information; Fracture; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 9 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: No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 10177064 ↗
• InjurySep 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 2 MONTHS POST IMPLANT OF THIS 22MM VALVED CONDUIT IN THE PULMONARY POSITION OF A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9129296 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P870078. One submission often covers many models, so check the product and lot details in each record.

• Z-2623-2014 · Aug 15, 2014 · Terminated
  Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for reli