The Recall Desk
HighFDA (Devices)·Z-1105-2022·Announced 2022-05-25

HeartWare HVAD Controller: Translation Errors in Critical Documentation

The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.

What this means for you

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: This recall involves a risk-of-harm product (ventricular assist device) where translation errors in critical patient documentation and emergency responder guides could impair proper device use or emergency response. Although no injuries have been reported and the FDA classified this as Class II rather than Class I, the life-critical nature of the device and the importance of clear patient and emergency documentation warrant a High severity rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has recalled 59 units of the HeartWare Ventricular Assist Device (HVAD) System Controller, Model 1420-Controller 2.0, manufactured by Heartware, Inc. The affected units were distributed in Finland and Turkey.

The recall is due to translation errors in Finnish and Turkish language versions of the device and its documentation. The erroneous translations appear in the controller and monitor display screens, as well as in the Instructions for Use, Patient Manual, and Emergency Responder Guide. These translation errors could impair a patient's or healthcare provider's understanding of how to properly operate the device or respond to emergencies.

Patients with this device should ensure that they can clearly understand all device documentation in their native language. If translation errors are identified or if questions arise about device operation or emergency procedures, patients should contact Heartware, Inc., or their healthcare provider immediately. The specific affected serial numbers are listed in the FDA recall notice.

The recalled product

Product
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac / Ventricular Assist Device
Hazard
Affected units
59

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 (20)

  • GTIN 00888707000420
  • Serial Numbers: CON306040
  • CON306041
  • CON306042
  • CON306044
  • CON306045
  • CON306046
  • CON306047
  • CON306085
  • CON306086
  • CON306087
  • CON306088
  • CON306089
  • CON306090
  • CON306093
  • CON306098
  • CON306120
  • CON306123
  • CON306125
  • CON306127

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Heartware, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Heartware, Inc.

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Same hazard · translation error

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