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Device recall: HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline
FDA enforcement event 76807 is a device recall by Heartware of Miami Lakes, FL, initiated 10 Mar 2017 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 3% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Heartware has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Heartware, Miami Lakes, FL.
Reason for recall
"In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available."
Distribution
"Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1832-2017 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side). | 9 units | Class I | Ongoing | 3 May 2017 |
Context
Other enforcement events for Heartware
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 May 2018 | Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Produc | Device | Class I | 1 |
| 3 Feb 2017 | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardia | Device | Class I | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.