Heartware, Inc. recalls
Every recall we track for Heartware, Inc. — 58 in all, from 2018–2023 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Heartware, Inc. peaked in 2021 (21); 58 since 2017. 3% rated “stop using now”.
All FDA recall records for Heartware, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 2 | 0 | 2 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 7 | 1 | 0 | 8 |
| 2021 | 2 | 8 | 10 | 1 | 21 |
| 2022 | 0 | 9 | 6 | 2 | 17 |
| 2023 | 0 | 0 | 10 | 0 | 10 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Heartware, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Heartware, Inc. recalls
18 shown- Lower riskMedical device
Heartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Heartware recalls PUMP 1103 HVAD implant kits with serial numbers starting from HW10991 to HW27250. Updates to instructions clarify when Controller Fault alarms occur and how to troubleshoot, plus information about component lifespan.
HeartwareOct 31, 2023 - Lower riskMedical device
Heartware, Inc. recalls HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor
Heartware recalls specific models of ventricular assist device monitors due to logfiles from updated units not being compatible with Autologs web portal. Affected units include 1521US, 1521GB, 1521IL, and 1521DE Explore Tech monitors with listed serial numbers.
HeartwareMay 16, 2023 - Use cautionMedical device
Heartware, Inc. recalls HeartWare Model 1100
Heartware recalls Model 1100 pacemakers with serial numbers HW001 to HW181 due to hardened driveline covers that may delay critical access, risking patient harm during emergencies.
HeartwareNov 29, 2022 - Lower riskMedical device
Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Heartware recalls HVAD System Batteries (Product Number 1650DE) due to battery performance issues that may cause failure to power the controller or accept charge. Affected units have specific serial numbers and GTIN.
HeartwareJun 28, 2022 - Lower riskMedical device
Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Heartware recalls HVAD System Controller Model 1407DE Kit due to Finnish and Turkish translation errors in displays and documentation. Affected units have specific serial numbers and GTINs.
HeartwareMar 30, 2022 - Lower riskMedical device
Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System
Heartware recalls specific HVAD system models for updated cleaning instructions to avoid removing lubricant from power connector pins, which could cause power switching issues.
HeartwareJan 27, 2022 - Lower riskMedical device
Heartware, Inc. recalls Medtronic HVAD Pump Implant Kits
Heartware recalls Medtronic HVAD Pump Implant Kits (product numbers 1100-1104JP, 1205, MCS1705PU) due to potential driveline repair complications during controller exchanges.
HeartwareAug 6, 2021 - Use cautionMedical device
Heartware, Inc. recalls HeartWare HVAD Pump Implant Kit, REF 1125
Heartware recalls HVAD Pump Implant Kit REF 1125 due to higher neurological adverse events and mortality risks compared to other LVADs, with internal pump failure concerns.
HeartwareJun 3, 2021 - UnratedMedical device
Heartware, Inc. recalls HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with
Heartware recalls HVAD Pump Implant Kit REF MCS170: Impeller shroud height may not meet safety limits. Affected patients should contact Heartware for guidance.
HeartwareMay 28, 2021 - Lower riskMedical device
Heartware, Inc. recalls Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile
Heartware recalls updated instructions for use and patient manuals for HVAD System components to address carrying case orientation, driveline cover safety, and power-up sequence clarity. These updates prevent potential misuse of the critical heart failure support device.
HeartwareFeb 26, 2021 - Lower riskMedical device
Heartware, Inc. recalls Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN,
Heartware recalls Medtronic HVAD Controller models 1400-1407 with potential port damage from cable misalignment. Affected users should contact Heartware for details.
HeartwareFeb 26, 2021 - Lower riskMedical device
Heartware, Inc. recalls Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump
Heartware recalls updated instructions for HeartWare HVAD system to address alarms that resolve quickly, which may indicate intermittent issues needing clinician evaluation.
HeartwareFeb 26, 2021 - Lower riskMedical device
Heartware, Inc. recalls Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump
Heartware recalls updated instructions for HVAD system to clarify controller connection verification using a beep instead of audible click. This correction helps users identify proper device connection without confusion.
HeartwareFeb 26, 2021 - Lower riskMedical device
Heartware, Inc. recalls Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101,
Heartware recalls Medtronic HVAD Pump Implant Kits with specific model numbers and serial ranges due to pumps failing to start or restart properly. Affected units include models 1100-1205 and specific serial numbers. No immediate action is required for safe use but may need monitoring.
HeartwareNov 19, 2020 - Use cautionMedical device
Heartware, Inc. recalls Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Heartware recalls HVAD Pump Implant Kit (REF 1103) due to risk of outflow graft tears and strain relief screw breakage during pre-implant assembly. Affected units have specific serial numbers and GTINs listed. Consumers should check their device details and contact Heartware for guidance.
HeartwareApr 3, 2020 - Use cautionMedical device
Heartware, Inc. recalls HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with
Heartware recalls HVAD System Battery Charger models with potential for incorrect AC adapter insertion into HVAD Controller power port. Affected units include specific model numbers and serials listed in the recall notice.
HeartwareJan 23, 2020 - Lower riskMedical device
Heartware, Inc. recalls Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare
Heartware recalls HVAD Battery Charger Model 1600US units with wrong inductors. These chargers may not charge batteries properly, risking system failure. Affected units have specific model numbers listed in the recall.
HeartwareNov 19, 2018 - Lower riskMedical device
Heartware, Inc. recalls Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The
Heartware recalls HVAD System Controllers (models 1403, 1407, 1420) due to potential hairline cracks at power ports from water/fluid exposure. Affected units have serial numbers CON300175 to CON320540.
HeartwareAug 28, 2018
Heartware, Inc. recall questions
How many recalls has Heartware, Inc. had?
58 recalls from Heartware, Inc. are on record with U.S. safety agencies, from 2018–2023.
What is the most recent Heartware, Inc. recall?
Heartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103, dated Oct 31, 2023. Every Heartware, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Heartware, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Heartware, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.