Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

FDA Recall Z-0067-2019 · Posted None

Recalling FirmHeartware, Inc.
Recall StatusTerminated
Product CodeDSQ
Date Initiated2018-08-28
Date Terminated2019-04-05
Product Quantity17,275 units

Reason for Recall

Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.

Firm Action

Medtronic began notifying Clinicians in the US on 28-Aug-2018 mainly via 2-day courier, of the identified issues and provided patient management recommendations. Outside the US, Medtronic began notifying Clinicians on 30-Aug-2018 via locally approved methods.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑