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

Recall Z-1339-2021 — Medtronic HVAD Monitor Data Cable, Product Number: 1575

U.S. FDA — Device Enforcement · United States · 2021-02-26 · Class I

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1339-2021
Date of alert
2021-02-26
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Heartware, Inc.
Product category
device
Product type
Devices
Reported risk: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
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.

Related

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.