Browse Device Recalls
61 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 61 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 61 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 31, 2023 | 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Mod... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numbe... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OU... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numb... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| May 16, 2023 | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech,... | Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monito... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104JP | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1205 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1102 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF MCS1705PU | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1103 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1101 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1100 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Jun 28, 2022 | HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1... | Battery performance issues. Battery electrical faults render it unable to power the controller, u... | Class I | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Nu... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HV... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONIT... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Mar 30, 2022 | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 14... | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instruc... | Class II | Heartware, Inc. |
| Jan 27, 2022 | HeartWare Ventricular Assist Device (HVAD) System | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and B... | Class II | Heartware, Inc. |
| Aug 6, 2021 | Medtronic HVAD Pump Implant Kits | There is more force required to slide the driveline cover (boot cover) away from the connector af... | Class II | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF MCS1705PU | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100US | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Implant Kit, REF 1104JP | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1104 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1103 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Driveline Extension Cable, REF 100 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Accessories, REF MCS1753AK | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Outflow Graft, REF MCS1725OG | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1153 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| Jun 3, 2021 | HeartWare HVAD Pump Implant Kit, REF 1125 | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... | Class I | Heartware, Inc. |
| May 28, 2021 | HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated fo... | The pump has an impeller with a shroud height that did not meet the lower control limit. | Class II | Heartware, Inc. |
| Feb 26, 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... | Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regard... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US... | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Alarm Adapter, Product Number: 1450 | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 142... | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Monitor Data Cable, Product Number: 1575 | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401... | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cable... | Class I | Heartware, Inc. |
| Feb 26, 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanie... | IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IF... | Class II | Heartware, Inc. |
| Feb 26, 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompani... | IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling ... | Class II | Heartware, Inc. |
| Nov 19, 2020 | Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... | Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... | Class I | Heartware, Inc. |
| Apr 3, 2020 | Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... | Class I | Heartware, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.