The Recall Desk
HighFDA (Devices)·Z-1107-2022·Announced 2022-05-25

HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, 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 FDA Class II recall involves critical medical device documentation with translation errors affecting a life-support system. While no illnesses or injuries are reported, errors in emergency responder guides and patient instructions for a life-critical device create potential for serious harm through misunderstanding of proper use and emergency procedures.

Plain-English summary

HeartWare, Inc. is recalling 645 units of the HeartWare Ventricular Assist Device (HVAD) System distributed to Finland and Turkey due to translation errors in Finnish and Turkish language documentation. The affected materials include the HVAD System Emergency Responder Guide, Instructions For Use, Patient Manual, and controller/monitor display text.

Translation errors in critical documentation may prevent patients, caregivers, and emergency responders from properly understanding device operation, maintenance, and emergency procedures. This could potentially lead to improper use or delayed response in emergencies.

Healthcare providers and patients using the HVAD System in affected regions should verify they have the correct language materials and contact HeartWare, Inc. directly for clarification on any unclear instructions or translations. Additional information is available from the FDA.

The recalled product

Product
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Fin
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiac Support / Ventricular Assist
Hazard
Affected units
645

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 (16)

  • No GTIN HVAD System Emergency Responder Guide (FI-Finnish)
  • Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish)
  • Lot Number: R025893 HVAD System Instructions For Use (FI)
  • Lot Number: R020771 HVAD System Instructions For Use (FI)
  • Lot Number: R020771 HVAD System Patient Manual (FI-Finnish)
  • Lot Number: R020769 HVAD System Patient Manual (FI-Finnish)
  • Lot Number: R021391 HVAD System Patient Manual (FI-Finnish)
  • Lot Number: R022265 HVAD System Instructions For Use - FI
  • Lot Number: R025606 HVAD System Instructions For Use (FI)
  • Lot Number: R028504 HVAD System OUS Patient Manual (FI-Finnish)
  • Lot Number: R028100 HVAD System Emergency Responder Guide (TR-Turkish)
  • Lot Number: R025877 HVAD System Patient Manual (TR-Turkish)
  • Lot Number: R021248 HVAD System Patient Manual (TR-Turkish)
  • Lot Number: R027179 HVAD System Patient Manual (TR-Turkish)
  • Lot Number: R027179 HVAD System OUS Instructions For Use (TR-Turkish)
  • Lot Number: R025760R01

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

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Same hazard · translation error

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