FDA Medical Device Recalls (openFDA)
Heartware, Inc.: PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
- Recall number
- Z-0481-2024
- Recalling firm
- Heartware, Inc.
- Product
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
- Status
- Open, Classified
- Initiated
- 2023-10-31
- Posted
- 2023-12-02
- Terminated
- not on file
- Reason
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Root cause
- Labeling design
- Action
- Heartware issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 10/31/2023 via letter (UPS). The notice explained the issue and informed them of the updates to the HVAD IFU and PM (patient manual).
- Quantity
- 126 units
- Distribution
- Worldwide
- Lot, serial or model codes
- GTIN none, Serial Numbers: HW25172, HW25169FSCA, HW25170FSCA, HW25174FSCA; GTIN 00763000170967, Serial numbers: HW42722, HW42771, HW42285, HW41696, HW41675, HW40953, HW41848, HW41847, HW41316, HW41828, HW41824, HW41803, HW41670, HW41271, HW41701, HW41674, HW41791, HW41792, HW41804, HW41252, HW41256, HW41700, HW41699, HW41783, HW41317, HW41309, HW41673, HW41254, HW40651, HW40665, HW40663, HW41672, HW41308, HW41269, HW41544, HW41270, HW41214, HW41314, HW40417, HW41263, HW41264, HW41265, HW41047, HW41260, HW41266, HW41251, HW41259, HW41258, HW40579, HW41048, HW41262, HW41045, HW40961, HW40958, HW40956, HW41050, HW41255, HW40881, HW40789, HW40957, HW40960, HW40951, HW40659, HW40602, HW40816, HW40954, HW40950, HW40662, HW40664, HW40580, HW40668, HW40613, HW40652, HW40666, HW40667, HW40660, HW40658, HW40612, HW40420, HW40657, HW40607, HW40552, HW40609, HW40599, HW40424, HW40423, HW40426, HW40600, HW40465, HW40553, HW40554, HW40383, HW40603, HW40653, HW40655, HW40656, HW40473, HW40555, HW40472, HW40422, HW40480, HW40564, HW40565, HW40413, HW40479, HW40557, HW40415, HW40476, HW40478, HW40428, HW40429, HW40477, HW40419, HW40421, HW40425, HW40431, HW40471, HW40474, HW40475, HW40412, HW40414, HW40418
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DSQ
- Firm FEI
- 3007042319
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28