Hancock™ HC15018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169646582), received between Jul 7, 2022 and Jul 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryJul 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A 12 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. IT WAS REPORTED THAT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED PRIOR TO THE EXPLANT PROCEDURE NOTED A "LARGE MASS JUST ABOVE THE VALVE". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14945810 ↗