FDA Device recall Z-1338-2021
Medtronic HVAD Alarm Adapter, Product Number: 1450
- FDA Device
- Class I
- ongoing
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class I recall of Medtronic HVAD Alarm Adapter, Product Number: 1450 by Heartware, citing there is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD C….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1338-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-02-26 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Heartware |
| Distribution | n/a |
Product
Medtronic HVAD Alarm Adapter, Product Number: 1450
Reason
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Heartware
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
FDA Device · Class II · 2023-12-13 · Heartware - 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
FDA Device · Class II · 2023-12-13 · Heartware - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
FDA Device · Class II · 2023-12-13 · Heartware - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
FDA Device · Class II · 2023-12-13 · Heartware - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA Device · Class II · 2023-12-13 · Heartware
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1338-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.