Hancock™ 150 HC150-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000926472), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION THAT THIS 14MM PULMONARY VALVED CONDUIT HAD AN ACTIVATED TEMPERATURE INDICATOR. IT WAS THEN CONFIRMED THAT THE DEVICE WAS IMPLANTED. THE SURGEON WAS INFORMED PRIOR TO USE OF THE DEVICE THAT THE CONDUIT SHOULD NOT BE USED IF THE TEMPERATURE INDICATOR IS ACTIVATED. SUBSEQUENTLY 8 DAYS LATER, THE VALVE WAS EXPLANTED. THE REASON FOR REPLACEMENT WAS REPORTED AS THE VALVE "WAS TOO BIG". IT WAS REPORTED THAT PRIOR TO USE, THE VALVE WAS STORED IN THE OPERATING ROOM WITH CONSTANT TEMPERATURE, ON AN OPEN CART. IT WAS STATED THAT THE OPERATING ROOM WAS THERMOSTAT CONTROLLED AND THE VALVE DID NOT EXPERIENCE KNOWN EXTREME TEMPERATURES. IT WAS NOTICED THAT THE TEMPERATURE INDICATOR HAD BEEN ACTIVATED AFTER BEING ON THE SHELF FOR APPROXIMATELY 3 WEEKS AND SOME OTHER VALVES STORED IN THE SAME LOCATION HAD INDICATORS WHICH STARTED TO ACTIVATE BUT WERE NOT FULLY BLACK. IT WAS REPORTED THAT THE VALVES WITH TEMPERATURE INDICATORS WHICH WERE NOT FULLY BLACK, HAVE BEEN LIKE THAT FOR AWHILE WITH NO CHANGE AND WERE ON THE SELF PRIOR TO THE HANCOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21708279 ↗