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, 1407I
Check against the official notice below — it lists the full affected range.
HeartWare HVAD System Labeling Update
HeartWare, Inc. is updating the Instructions for Use and Patient Manual for the HeartWare HVAD System to correct information about how users verify the controller connection. The original labeling described the successful connection as producing an "audible click," but the actual verified behavior is a "beep" sound. The updated labeling will also clarify when a beep will not be heard during certain alarm conditions and will identify a visual indicator as an alternate confirmation method for successful connection. This labeling correction applies to multiple HVAD pump implant kit models (1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and M) and has been distributed worldwide, including throughout the United States and in Italy, Great Britain, Germany, and Japan.
Approximately 23,123 units of affected labeling have been distributed, with 11,292 units in the United States. The record does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan. Quantity: 23123 (11292 US) Lot/code info: 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;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.