HANCOCK® HC105-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00681490908597), received between May 1, 2018 and Jan 6, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A 10 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM 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 16113155 ↗
• InjuryMay 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNSPECIFIED DURATION POST IMPLANT OF THIS 20MM AORTIC VALVED CONDUIT IN A 12 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 21MM NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14519358 ↗
• InjuryJan 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 20 MM PULMONARY BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25 MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13342814 ↗
• InjuryOct 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS 20MM 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 12642386 ↗
• InjuryNov 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 1 MONTH POST IMPLANT OF THIS 20MM 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 REPORTED AS MODERATE-SEVERE PULMONARY REGURGITATION WITH MILD STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 10920072 ↗
• InjuryJan 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 8 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: Aortic Valve Stenosis; No Information

  MAUDE report 8282769 ↗
• InjuryNov 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 2 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IN AN 8 YEAR OLD PEDIATRIC PATIENT, 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

  MAUDE report 8085183 ↗
• InjuryMay 11, 2018Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS POST IMPLANT OF THIS BIOPROSTHETIC VALVED CONDUIT, IMPLANTED IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS MODERATE TO SEVERE STENOSIS. SIX YEARS AND NINE MONTHS POST VALVE-IN-VALVE, BOTH PRODUCTS WERE EXPLANTED AND REPLACED WITH ANOTHER BIOPROSTHETIC VALVED CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Corneal Pannus; Pulmonary Valve Stenosis

  MAUDE report 7508889 ↗
• InjuryMay 1, 2018Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS AND TWO MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE IN A SEVEN YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO A GRADIENT MEASUREMENT OF 90MMHG, REGURGITATION AND STENOSIS. PRIOR TO REPLACEMENT, AN ECHOCARDIOGRAM (ECG) WAS PERFORMED THAT REVEALED THE GRADIENT MEASUREMENT WHILE THE PATIENT WAS EXERCISING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 7476439 ↗

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