The Recall Desk
SevereFDA (Devices)·Z-1427-2020·Announced 2020-03-18

HeartWare HVAD System Battery Charger Recalled for Adapter Insertion Risk

Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers because users may mistakenly insert the AC adapter into the HVAD Controller power port.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.

Plain-English summary

Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Chargers (Model Number 1610, all Serial Numbers). The recall is due to a potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure, either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT). No affected devices were distributed within the US. International distribution included Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

The FDA has classified this recall as Class I. Consumers and healthcare providers should verify the model and serial numbers of their devices against the recall list and contact Heartware, Inc. for further instructions.

The recalled product

Product
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT)
Manufacturer
Heartware, Inc.
Category
Medical Device — Cardiovascular
Hazard
Affected units
5,489

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)

  • Model Number: 1610
  • 1610GB (BCH000002) 00888707002219
  • 1610DE (BCH000003) 00888707002202
  • 1610DE (BCH000004) 00888707002202
  • 1610IT (BCH000005) 00888707002240
  • 1610IT (BCH000006) 00888707002240
  • 1610DE (BCH000007) 00888707002202
  • 1610DE (BCH000008) 00888707002202
  • 1610CH (BCH000010) 00888707002196
  • 1610DE (BCH000011) 00888707002202
  • 1610DE (BCH000012) 00888707002202
  • 1610CH (BCH000013) 00888707002196
  • 1610IT (BCH000014) 00888707002240
  • 1610DE (BCH000015) 00888707002202
  • 1610DE (BCH000017) 00888707002202
  • 1610DE (BCH000018) 00888707002202
  • 1610DE (BCH000019) 00888707002202
  • 1610IT (BCH000020) 00888707002240
  • 1610DE (BCH000021) 00888707002202
  • 1610GB (BCH000022) 00888707002219

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Heartware, Inc.

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Same hazard · incorrect insertion

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