The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1887-2016·Announced 2016-07-20

Heartware Ventricular Assist System Battery Recall for Premature Depletion

Heartware, Inc. is recalling 18,631 HeartWare Ventricular Assist System batteries due to premature depletion. The recall covers devices distributed nationwide in the US.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

Heartware, Inc. is recalling 18,631 units of the HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V. The recall is due to the battery cell experiencing premature depletion. The affected product is used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.

The recall covers serial numbers ranging from BAT000001 to BAT199999. The product was distributed nationwide in the United States, including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.

The FDA has classified this recall as Class I. Patients using these devices should contact their healthcare provider or Heartware, Inc. for instructions on how to proceed.

The recalled product

Product
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left…
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiovascular
Hazard

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 numbers ranging BAT000001 to BAT199999.

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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