Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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).

U.S. FDA — Device Enforcement · United States · 2017-03-10 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1832-2017
Date of alert: 2017-03-10
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Heartware
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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