HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2072-2021.
The pump has an impeller with a shroud height that did not meet the lower control limit.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2072-2021.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Heartware, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2072-2021.
Heartware, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Heartware, Inc. Recall FAQ
Heartware, Inc. is the subject of a medical implants safety report: HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory .... The notice was published on May 28, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 1 units are potentially affected.