Heartware, Inc.
FDA Regulatory Profile
Heartware, Inc. appears in FDA public data with 75 recalls — including 38 Class I (most serious) —, 1 510(k) clearance, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0483-2024, Class II) was initiated on October 31, 2023. Its most recent 510(k) clearance was granted on October 16, 1997.
Summary
- Total Recalls
- 75 (38 Class I)
- 510(k) Clearances
- 1
- Inspections
- 7
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0483-2024 | Class II | PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU | October 31, 2023 |
| Z-0481-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP | October 31, 2023 |
| Z-0482-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 | October 31, 2023 |
| Z-0476-2024 | Class II | STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 | October 31, 2023 |
| Z-0479-2024 | Class II | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 | October 31, 2023 |
| Z-0477-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 | October 31, 2023 |
| Z-0478-2024 | Class II | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 | October 31, 2023 |
| Z-0475-2024 | Class II | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 | October 31, 2023 |
| Z-0480-2024 | Class II | 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN | October 31, 2023 |
| Z-1993-2023 | Class II | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Exp | May 16, 2023 |
| Z-0743-2023 | Class II | HeartWare Model 1101 | November 29, 2022 |
| Z-0747-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | November 29, 2022 |
| Z-0750-2023 | Class II | HeartWare HVAD Pump Kit, REF MCS1705PU | November 29, 2022 |
| Z-0746-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104 | November 29, 2022 |
| Z-0744-2023 | Class II | HeartWare Model 1102 | November 29, 2022 |
| Z-0749-2023 | Class II | HeartWare HVAD Pump Kit, REF 1205 | November 29, 2022 |
| Z-0748-2023 | Class II | HeartWare HVAD Pump Kit, REF 1104JP | November 29, 2022 |
| Z-0742-2023 | Class II | HeartWare Model 1100 | November 29, 2022 |
| Z-0745-2023 | Class II | HeartWare HVAD Pump Kit, REF 1103 | November 29, 2022 |
| Z-1512-2022 | Class I | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE | June 28, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K972229 | IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM | October 16, 1997 |