HANCOCK® HC150-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490908740), received between Feb 12, 2019 and Jun 23, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S MOTHER THAT APPROXIMATELY 10 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6)-MONTH-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10184351 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS AND TEN MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN AN INFANT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH AN 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WASN'T REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8334179 ↗