Hancock™ HC105-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169646520), received between Mar 18, 2020 and Jul 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. 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.

• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 12173381 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS 20MM BIOPROSTHETIC VALVED CONDUIT IN THE PULMONARY POSITION, IT WAS EXPLANTED AND DISCARDED. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Obstruction/Occlusion

  MAUDE report 9848049 ↗

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