Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ALL SERIAL NUMBERS UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement 1403: 00888707000116, 00888707000475 1407: '00888707000291, '00888707000727, '00888707000710, 00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472 1420: '00888707000420, '00888707000437, '00888707002660 (b) 1435: '00888707000109 1440: '00888707000260, '00888707001885, '00888707001496, '00888707002745 (c) 1425: '00888707000093 1430: '00888707000307, '00888707000826, '00888707000833, '00888707000840, '00888707000857, '00888707000871, '00888707000864, '00888707000888, '00888707000901, '00888707000505, '00888707000895, '00888707000918, '00888707001489, '00888707001779, '00888707001786, '00888707001793, '00888707001809, '00888707001816, '00888707001823, '00888707001830, '00888707001847, '00888707001854, '00888707001861, '00888707001878, '00888707002738, '00888707002769, '00888707002776, '00888707002783, '00888707002790, '00888707002806, '00888707004817 (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653, '00888707000376
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Heartware
- Reason for Recall:
- Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death from refractory end-stage heart failure. The HVAD System is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
Product Codes/Lot Numbers:
ALL SERIAL NUMBERS UPN/GTIN: (a) 1400 and 1401: distributed prior to GTN requirement 1403: 00888707000116, 00888707000475 1407: '00888707000291, '00888707000727, '00888707000710, 00888707000734, '00888707000741, '00888707000765, '00888707000758, '00888707000789, '00888707000772, '00888707000499, '00888707000796, '00888707000802, '00888707000819, '00888707000482, '00888707004534, '0888707001670, '00888707001656, '00888707001663, '00888707001670, '00888707001687, '00888707001694, '00888707001700, '00888707001717, '00888707001724, '00888707001731, '00888707001748, '00888707001755, '00888707001762, '00888707002813, '00888707002820, '00888707002837, '00888707002844, '00888707002851, '00888707001472 1420: '00888707000420, '00888707000437, '00888707002660 (b) 1435: '00888707000109 1440: '00888707000260, '00888707001885, '00888707001496, '00888707002745 (c) 1425: '00888707000093 1430: '00888707000307, '00888707000826, '00888707000833, '00888707000840, '00888707000857, '00888707000871, '00888707000864, '00888707000888, '00888707000901, '00888707000505, '00888707000895, '00888707000918, '00888707001489, '00888707001779, '00888707001786, '00888707001793, '00888707001809, '00888707001816, '00888707001823, '00888707001830, '00888707001847, '00888707001854, '00888707001861, '00888707001878, '00888707002738, '00888707002769, '00888707002776, '00888707002783, '00888707002790, '00888707002806, '00888707004817 (d) 1650DE: 00888707000369, 00888707001373, '00888707001588, '00888707001366, '00888707002684 '00888707002646, '00888707002653, '00888707000376
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1903-2018
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