The Recall Desk
HighFDA (Devices)·Z-1102-2022·Announced 2022-05-25

HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.

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 is a risk-of-harm product (life-sustaining ventricular assist device) where translation errors in critical instructions and patient manuals could affect proper device operation and understanding. No injuries have been reported, which prevents a higher severity classification per the rubric.

Plain-English summary

HeartWare, Inc. is recalling 236 units of the HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit (Model Number 1104) due to translation errors in Finnish and Turkish. The errors appear in the controller display, monitor display, Instructions for Use, Patient Manual, and Emergency Responder Guide.

The affected devices were distributed in Finland and Turkey. Multiple specific serial numbers have been identified for the recalled units, each associated with Global Trade Item Numbers (GTINs) as documented by the FDA.

The recalled product

Product
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Assist
Hazard
Affected units
236

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 00888707000598
  • Serial Numbers: HW28827 GTIN 00888707001649
  • Serial Numbers: HW29474
  • HW29864
  • HW29985
  • HW30222
  • HW31506
  • HW31511
  • HW32021
  • HW32255
  • HW32301
  • HW34343
  • HW35068
  • HW35085
  • HW35290
  • HW35311
  • HW35349
  • HW35559
  • HW35657
  • HW35662

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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