Heartware, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2057-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP

Product Classification:

Class I

Date Initiated: April 3, 2020

Date Posted: June 3, 2020

Recall Number: Z-2057-2020

Event ID: 85397

Reason for Recall:

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Status: Ongoing

Product Quantity: 85 units

Code Information:

GTIN 00888707000697, Serial numbers: HW34700, HW34703, HW34710, HW34713 GTIN 00888707005838, Serial Numbers: HW40383, HW40412, HW40413, HW40414, HW40415, HW40417, HW40418, HW40419, HW40420, HW40421, HW40422, HW40423, HW40424, HW40425, HW40426, HW40428, HW40429, HW40431, HW40465, HW40471, HW40472, HW40473, HW40474, HW40475, HW40476, HW40477, HW40478, HW40479, HW40480, HW40552, HW40553, HW40554, HW40555, HW40556, HW40557, HW40564, HW40565, HW40580, HW40599, HW40600, HW40602, HW40603, HW40604, HW40607, HW40609, HW40611, HW40612, HW40613, HW40649, HW40650, HW40651, HW40652, HW40653, HW40655, HW40656, HW40657, HW40658, HW40659, HW40660, HW40661, HW40662, HW40663, HW40664, HW40666, HW40667, HW40668, HW40789, HW40816, HW40881, HW40950, HW40951, HW40952, HW40953, HW40954, HW40955, HW40956, HW40957, HW40958, HW40960, HW40961, HW41045

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated