Heartware, Inc. Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD co Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD co
Brand
Heartware, Inc.
Lot Codes / Batch Numbers
Model, GTIN: 1100, No GTIN Available, 1101, No GTIN Available, 1102, No GTIN Available, 1103, 00888707000017, 1104, No GTIN Available, 1104JP, 00888707000697, 1205, No GTIN Available, MCS1705PU, 00888707005364, 1403US, 00888707000475, 1407AU, 00888707001663, 1407CA, 00888707002851, 1407CH, 00888707001694, 1407DE, 00888707001700, 1407GB, 00888707001717, 1407IL, 00888707001724, 1407IN, 00888707001731, 1407IT, 00888707001748, 1407JP, 00888707001755, 1407KR, 00888707001762, 1420, 00888707000420, 1420JP, 00888707000437, 1430AR, 00888707000826, 1430AU, 00888707000833, 1430CA, 00888707000857, 1430CH, 00888707000871, 1430DE, 00888707000864, 1430GB, 00888707000888, 1430IL, 00888707000901, 1430IN, 00888707000505, 1430IT, 00888707000895, 1430JP, 00888707000918, 1430US, 00888707000307, 1440, 00888707001885, 1575, 00888707008051, 1650, 00888707000376, 1650CA-CLIN, 00888707001588, 1650DE, 00888707001373, 1475, 00888707008037, 2050, 00888707008082, 2050IL, 00888707001410, 2050US, 00888707000048, 2060, 00888707008099, 2060IL, 00888707001427, 2060US, 00888707000055
Products Sold
Model, GTIN: 1100, No GTIN Available; 1101, No GTIN Available; 1102, No GTIN Available; 1103, 00888707000017; 1104, No GTIN Available; 1104JP, 00888707000697; 1205, No GTIN Available; MCS1705PU, 00888707005364; 1403US, 00888707000475; 1407AU, 00888707001663; 1407CA, 00888707002851; 1407CH, 00888707001694; 1407DE, 00888707001700; 1407GB, 00888707001717; 1407IL, 00888707001724; 1407IN, 00888707001731; 1407IT, 00888707001748; 1407JP, 00888707001755; 1407KR, 00888707001762; 1420, 00888707000420; 1420JP, 00888707000437; 1430AR, 00888707000826; 1430AU, 00888707000833; 1430CA, 00888707000857; 1430CH, 00888707000871; 1430DE, 00888707000864; 1430GB, 00888707000888; 1430IL, 00888707000901; 1430IN, 00888707000505; 1430IT, 00888707000895; 1430JP, 00888707000918; 1430US, 00888707000307; 1440, 00888707001885; 1575, 00888707008051; 1650, 00888707000376; 1650CA-CLIN, 00888707001588; 1650DE, 00888707001373; 1475, 00888707008037; 2050, 00888707008082; 2050IL, 00888707001410; 2050US, 00888707000048; 2060, 00888707008099; 2060IL, 00888707001427; 2060US, 00888707000055;
Heartware, Inc. is recalling Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartw due to IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified beh. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603
Recommended Action
Per FDA guidance
Beginning 26-Feb-2021, an Urgent Medical Device Recall notification was disseminated to consignees who Medtronic records indicate have received affected product, UPS 2-day delivery. The notices provided updated information for the instructions for use and patient manual.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026