The Recall Desk

Manufacturer

Heartware, Inc.

72 recalls in our database name Heartware, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
72
Critical
13
Severe
11
Most recent
2023-12-13

Of the 72 recalls from Heartware, Inc. we have scored against our rubric, 13 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (15%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 72

  • ModerateFDA (Devices)·Z-1103-2022·2022-05-25

    HeartWare HVAD System Controller Recalled for Translation Errors in Documentation

    Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0726-2022·2022-03-16

    HeartWare HVAD System: Updated Cleaning Instructions for Power Connectors

    Updated cleaning instructions are being provided for the HeartWare HVAD System's power connectors. Improper cleaning can remove protective lubricant required for proper power switching.

    Product
    HeartWare Ventricular Assist Device (HVAD) System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2478-2021·2021-09-22

    Medtronic HVAD Pump Implants: Driveline Cover May Impede Connector Access

    Medtronic HVAD Pump Implant Kits may require increased force to remove the driveline cover after strain relief repair, potentially making controller exchanges difficult and risking further repair damage.

    Product
    Medtronic HVAD Pump Implant Kits
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2190-2021·2021-08-18

    HeartWare HVAD heart pump implants recalled for neurological events and mortality

    Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2194-2021·2021-08-18

    HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF 1104JP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2195-2021·2021-08-18

    HeartWare HVAD Implant Kit Recalled Over Higher Mortality Rates

    Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2197-2021·2021-08-18

    Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures

    Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.

    Product
    HeartWare HVAD Pump Accessories, REF MCS1753AK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2192-2021·2021-08-18

    HeartWare HVAD System Recalled Due to Higher Mortality Rates

    Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2191-2021·2021-08-18

    HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure

    Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1153
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2193-2021·2021-08-18

    HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns

    Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2196-2021·2021-08-18

    Heartware HVAD ventricular assist device recalled due to mortality risk

    Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.

    Product
    HeartWare HVAD Outflow Graft, REF MCS1725OG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2188-2021·2021-08-18

    FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2189-2021·2021-08-18

    Heart Pump Device Recalled for Increased Mortality and Device Failure

    Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2021·2021-07-21

    HeartWare HVAD Pump Implant Kit Impeller Defect Recall

    HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.

    Product
    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in pat
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1469-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Recall

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HeartWare HVAD System to update guidance on intermittent alarm issues.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2021·2021-04-28

    HeartWare HVAD Instructions for Use and Patient Manual Labeling Correction

    Heartware, Inc. is recalling Instructions for Use and Patient Manuals for the HVAD System to correct inaccurate descriptions of controller connection verification.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1426-2021·2021-04-28

    HeartWare HVAD System Manual Updates for Carrying Cases and Driveline Cover

    Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1337-2021·2021-04-14

    Medtronic HVAD Controller Power Cables Recalled for Port Damage Risk

    Heartware, Inc. is recalling Medtronic HVAD Controller power and data cables due to a risk of damaging controller ports from cable misalignment.

    Product
    Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 14
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1336-2021·2021-04-14

    Medtronic HVAD Controller Recall for Potential Port Damage

    Heartware is recalling Medtronic HVAD Controllers because power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1340-2021·2021-04-14

    Medtronic HVAD Battery Recall for Potential Controller Port Damage

    Heartware, Inc. is recalling Medtronic HVAD Batteries because controller power and data cables may damage controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1338-2021·2021-04-14

    Medtronic HVAD Alarm Adapter Recalled for Potential Port Damage

    Heartware, Inc. is recalling 418 Medtronic HVAD Alarm Adapters because cable misalignment may cause damage to the HVAD Controller ports.

    Product
    Medtronic HVAD Alarm Adapter, Product Number: 1450
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1341-2021·2021-04-14

    Medtronic HVAD Monitor Recall Due to Cable Port Damage Risk

    Heartware is recalling Medtronic HVAD Packaged Monitors because worn cables may damage controller ports during insertion.

    Product
    Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 15
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1339-2021·2021-04-14

    Medtronic HVAD Monitor Data Cable Recalled for Potential Port Damage

    Heartware, Inc. is recalling Medtronic HVAD Monitor Data Cables because they may damage HVAD Controller ports due to wear from misalignment.

    Product
    Medtronic HVAD Monitor Data Cable, Product Number: 1575
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0946-2021·2021-02-10

    Medtronic HVAD Pump Implant Kits Recalled for Startup Failures

    Heartware, Inc. is recalling 19,562 Medtronic HVAD Pump Implant Kits because they may fail to start or restart at a higher rate than expected.

    Product
    Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide