HANCOCK® HC150-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00681490908726), received between Feb 21, 2017 and Apr 22, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Expiration Date Error; Expiration Date Error

  MEDTRONIC RECEIVED INFORMATION THAT THIS 12MM PULMONARY VALVED CONDUIT WAS IMPLANTED AT A DATE PAST THE PRODUCT EXPIRATION DATE. THE DEVICE REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19152141 ↗
• InjuryMar 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT, 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 19004900 ↗
• InjuryJun 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 12MM VALVED CONDUIT, THE CONDUIT WAS EXPLANTED AND REPLACED. THE REASON FOR REPLACEMENT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7637600 ↗
• InjuryOct 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 7 MONTHS POST IMPLANT OF THIS 12MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC 16MM PULMONARY VALVED CONDUIT DUE TO SEVERE PULMONARY STENOSIS. DURING THE PROCEDURE, THE PHYSICIAN PERFORMED A VSD CLOSURE AND BIFURCATION PLASTY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 6917271 ↗
• InjuryFeb 21, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 6347035 ↗