The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1131-2015·Announced 2015-03-04

HeartWare Controller Recall Due to Higher Susceptibility to Electrostatic Discharge

HeartWare Inc is recalling 4,845 HeartWare Controllers used in ventricular assist systems because they are more susceptible to electrostatic discharge (ESD) than newer models.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers."

Plain-English summary

HeartWare Inc is recalling 4,845 HeartWare Controllers, which are components of the HeartWare Ventricular Assist System. These devices are used as a bridge-to-cardiac transplantation for patients at risk of death from refractory end-stage left ventricular heart failure. The recall covers units distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and South America.

The recall was initiated because the affected clinical trial Controllers exhibit a higher susceptibility to electrostatic discharge (ESD) than newer commercial Controllers. The affected units are identified by Model Numbers 1400 and 1401US (US) or 1401XX (International), with serial numbers ranging from CON000001 through CON005472.

Patients and healthcare providers using these specific controllers should contact HeartWare Inc or their medical device representative for instructions on how to proceed. The source text does not specify a particular action for consumers beyond the recall notice itself, but standard procedure for medical device recalls involves immediate consultation with the manufacturer or healthcare provider.

The recalled product

Product
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and…
Manufacturer
HeartWare Inc
Category
Medical Device — Cardiovascular
Hazard
Affected units
4,845

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 (3)

  • Product Codes- US product: Model No.: 1400
  • 1401US
  • International product: Model No.: 1400

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

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