[Recalled] 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 driv
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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). |
|---|---|
| Brand / manufacturer | Heartware |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1832-2017 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 10 March 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.