| Supplemental Warranty | Warranty Summary | Expires |
|---|---|---|
| HVAD System: Power Switching |
Where HVAD power source(s) has experienced unexpected power switching behavior and unexpected audible tones, Medtronic will initially provide power source replacement(s), without charge, to the warranty holder. If the unexpected behavior persists, after replacement of the HVAD power source(s), Medtronic will provide an HVAD Controller, without charge, to the warranty holder. | December 15, 2022 |
| HVAD: Failure to Restart Controller Exchange |
Where patients with an affected device in the failure to restart subset have a primary controller beyond two (2) years of service and the physician has made the medical judgment that prophylactic exchange of the primary controller is in the individual patient’s best interests, the warranty holder is eligible for: a replacement of (2) controllers (i.e., one “primary” and one “backup” controller) per patient with an Affected Device, at no charge. | December 15, 2022 |
| HVAD: Failure to Restart Non-Prophylactic Pump Exchange |
For Non-Prophylactic exchange due to any device failure to restart at any time in patients with an affected device from the December 2020 Product Advisory:
|
December 15, 2022 |
| HVAD: Failure to Restart Prophylactic Pump Exchange |
For Prophylactic exchanges of an HVAD Pump serial number that is in the subset of “Affected Devices” from the December 2020 Product Advisory where the physician has made the medical judgment that the prophylactic exchange, although not recommended by Medtronic, is in the individual patient’s best interests:
|
December 15, 2022 |
| HVAD: Prophylactic Pump Exchange for Non-Recalled Devices |
For Prophylactic exchanges of an HVAD Pump serial number that is outside of the subset of “Affected Devices” from the December 2020 Product Advisory where the physician has made the medical judgment that the prophylactic exchange, although not recommended by Medtronic, is in the individual patient’s best interests: Patient Support. Patients are eligible to apply for up to $10,000 in URM expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses). |
December 15, 2022 |
| HVAD: Pump Weld Non-Prophylactic Exchanges |
Replacement System: Warranty holders are eligible for a warranty credit in the amount of the cost of an HVAD System. If an insurance claim is denied, warranty holders are also eligible for 150% of the hospital specific DRG payment. Patient Support: Patients are eligible to apply for up to $10,000 in Unreimbursed Medical (URM) expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses). |
December 15, 2022 |
| HVAD: Pump Weld Non-Prophylactic Pump Removal |
For Non-Prophylactic removal which results in a transplant: Patient Support: Patients are eligible to apply for up to $10,000 in Unreimbursed Medical (URM) expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses). |
December 15, 2022 |
| HVAD: Pump Weld Prophylactic Exchanges |
Where the physician has made the medical judegment that the prophylactic exchange, although not recommended by Medtronic, is in the individual patient's best interests: Patient Support: Patients are eligible to apply for up to $10,000 in Unreimbursed Medical (URM) expenses associated with the patient’s portion of costs of the HVAD System exchange procedure to a competitive device (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients, travel expenses). |
December 15, 2022 |
| HVAD: Battery Performance Issue |
Where an interaction between the battery software configuration and the battery circuit board which can result in electrical faults within some batteries causing possible loss of battery performance (as previously identified in the June 26, 2022 customer communication, Medtronic Heartware™ Ventricular Assist Device (HVAD™) System Battery Performance Update), the warranty holder is eligible for: replacement of one or more Medtronic Heartware™ Batteries. | December 15, 2022 |
| HVAD: Bent Pins |
Where power sources and monitor cables have caused damage to the controller ports due to misalignment when instering the cables. The warranty holder is eligible for: the replacement of all patient batteries, patient AC and DC adapters, and the replacement of monitor data cables. Patient Support: Patients are eligible to apply for up to $2000 in Unreimbursed Medical (URM) expenses related to travel, outside of a normal clinic visit, to their VAD center for the exchange of product outlined in the FCA (inclusive of any co-pays, coinsurance or deductibles paid or owed by patients and/or travel expenses). Receipts for all reimbursable expenses are required. |
December 15, 2023 |