The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1428-2020·Announced 2020-03-18

Heartware Recalls HVAD System Battery Charger AC Adapters

Heartware, Inc. is recalling 5,489 HVAD System Battery Charger AC Adapters because users might mistakenly insert them into the HVAD Controller power port.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port."

Plain-English summary

Heartware, Inc. is recalling 5,489 HeartWare HVAD System Battery Charger AC Adapters. The recall was initiated because there is a potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

The affected devices are Model Number 1640, all Serial Numbers. 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) in patients for whom subsequent transplantation is not planned.

No affected devices were distributed within the United States. The devices were distributed internationally to numerous countries, including 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. Consumers should check their device model and serial numbers against the recall list and contact Heartware, Inc. for instructions.

The recalled product

Product
HeartWare HVAD System Battery Charger AC Adapter 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…
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: 1640
  • 1640GB (BAC004765) 00888707001328
  • 1640GB (BAC004768) 00888707001328
  • 1640AR (BAC004772) 00888707001274
  • 1640IN (BAC004829) 00888707000543
  • 1640DE (BAC005530) 00888707001304
  • 1640CA (BAC005842) 00888707001298
  • 1640CA (BAC005854) 00888707001298
  • 1640BR (BAC005875) 00888707001281
  • 1640BR (BAC005876) 00888707001281
  • 1640GB (BAC005920) 00888707001328
  • 1640AU (BAC005966) 00888707001267
  • 1640AU (BAC005980) 00888707001267
  • 1640IN (BAC005997) 00888707000543
  • 1640AU (BAC006001) 00888707001267
  • 1640IL (BAC006027) 00888707001335
  • 1640IT (BAC006032) 00888707001342
  • 1640IN (BAC006033) 00888707000543
  • 1640IN (BAC006034) 00888707000543
  • 1640IN (BAC006035) 00888707000543

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.

See all →

Same hazard · incorrect insertion

See all →

Similar recalls