← Every firm
Heartware, Inc. FDA Recalls
48 recalls on file across devices, 18 of them Class I and 47 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103Class IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLINClass IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102Class IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PUClass IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205Class IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JPClass IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100Class IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104Class IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101Class IIOct 31, 2023Updates to the HVAD system instructions for use (IFU) and pa |
| HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) MonitClass IIMay 16, 2023Medtronic has identified that the logfiles downloaded from t |
| HeartWare HVAD Pump Kit, REF 1205Class IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare HVAD Pump Kit, REF 1104CA-CLINClass IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare HVAD Pump Kit, REF 1103Class IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare Model 1102Class IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare HVAD Pump Kit, REF MCS1705PUClass IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare HVAD Pump Kit, REF 1104JPClass IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare Model 1101Class IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare Model 1100Class IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare HVAD Pump Kit, REF 1104Class IINov 29, 2022Over time, the driveline cover may become hardened, creating |
| HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DEClass IJun 28, 2022Battery performance issues. Battery electrical faults render |
| HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-FiClass IIMar 30, 2022Finnish and Turkish translation errors in HVAD controller an |
| HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0Class IIMar 30, 2022Finnish and Turkish translation errors in HVAD controller an |
| HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECHClass IIMar 30, 2022Finnish and Turkish translation errors in HVAD controller an |
| HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420Class IIMar 30, 2022Finnish and Turkish translation errors in HVAD controller an |
| HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE KitClass IIMar 30, 2022Finnish and Turkish translation errors in HVAD controller an |
| HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104Class IIMar 30, 2022Finnish and Turkish translation errors in HVAD controller an |
| HeartWare Ventricular Assist Device (HVAD) SystemClass IIJan 27, 2022Updated cleaning instructions are being provided for the Con |
| Medtronic HVAD Pump Implant KitsClass IIAug 6, 2021There is more force required to slide the driveline cover (b |
| HeartWare HVAD Outflow Graft, REF MCS1725OGClass IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Pump Implant Kit, REF 1125Class IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Pump Implant Kit, REF 1153Class IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Pump Implant Kit, REF 1103Class IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Driveline Extension Cable, REF 100USClass IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Implant Kit, REF MCS1705PUClass IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Pump Accessories, REF MCS1753AKClass IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Pump Implant Kit, REF 1104Class IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Implant Kit, REF 1104JPClass IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare HVAD Driveline Extension Cable, REF 100Class IJun 3, 2021Medtronic is stopping the distribution and sale of the HVAD |
| HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advaClass IIMay 28, 2021The pump has an impeller with a shroud height that did not m |
| Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implanClass IIFeb 26, 2021IFU and Patient Manual updated to describe Expected Alarm Du |
| Medtronic HVAD Alarm Adapter, Product Number: 1450Class IFeb 26, 2021There is the potential for the Controller power cables (AC A |
| Medtronic HVAD Monitor Data Cable, Product Number: 1575Class IFeb 26, 2021There is the potential for the Controller power cables (AC A |
| Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1Class IFeb 26, 2021There is the potential for the Controller power cables (AC A |
| Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DEClass IFeb 26, 2021There is the potential for the Controller power cables (AC A |
| Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425ITClass IFeb 26, 2021There is the potential for the Controller power cables (AC A |
| Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile ImClass IFeb 26, 2021Medtronic HeartWare HVAD System Instructions for Use (IFU) a |
| Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN,Class IFeb 26, 2021There is the potential for the Controller power cables (AC A |
| Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implClass IIFeb 26, 2021IFU and Patient Manual updated to describe HVAD Controller C |