The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0067-2019·Announced 2018-10-10

Heartware HVAD System Controllers Recalled for Potential Water Ingress

Heartware, Inc. is recalling HVAD System Controllers because they may develop hairline cracks at the power ports, potentially failing to meet standards for protection against water or fluid ingress.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a defect could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Heartware, Inc. is recalling HeartWare HVAD System Controllers and Controller Kits, model numbers 1403, 1407, and 1420. The recall involves 17,275 units with serial numbers ranging from CON300175 to CON320540. These devices were distributed worldwide.

The recall was initiated because certain controller units may not meet the labeled standard for protection against water or fluid ingress. Specifically, the units have the potential to develop hairline cracks at the power ports of the controller housing.

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). Patients using these devices should contact their healthcare provider or Heartware, Inc. for further instructions regarding the recall.

The recalled product

Product
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…
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
17,275

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial number range: CON300175 - CON320540

Distribution

Distribution scope not specified by the agency.

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