Heartware HVAD Pump Implant Kit Recall: Impeller Shroud Height Risk
Heartware recalls HVAD Pump Implant Kit REF MCS170: Impeller shroud height may not meet safety limits. Affected patients should contact Heartware for guidance.
Recall notice
The pump has an impeller with a shroud height that did not meet the lower control limit.
Contact the company
What happened, in plain English
Heartware is recalling its HVAD Pump Implant Kit (REF MCS1705PU) because the pump's impeller shroud height might be too low, potentially causing safety issues. This recall affects patients with advanced heart failure who use the device for hemodynamic support. Read more at govinfonow.com/recall/62447-heartware-hvad-pump-implant-kit-recall-impeller-shroud-height-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62447-heartware-hvad-pump-implant-kit-recall-impeller-shroud-height-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2072-2021
Cite this page
“Heartware HVAD Pump Implant Kit Recall: Impeller Shroud Height Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62447-heartware-hvad-pump-implant-kit-recall-impeller-shroud-height-risk. Based on FDA recall #Z-2072-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2072-2021%22&limit=1).
Why it’s dangerous
The pump's impeller shroud height did not meet the lower control limit, which could lead to improper function. This might cause the device to fail in supporting heart function, especially in patients with severe heart failure.
Who’s affected
Patients with advanced, refractory left ventricular heart failure who use the Heartware HVAD Pump Implant Kit for hemodynamic support are affected. Those who have the specific model REF MCS1705PU are most at risk.
How to tell if you have this one
Check for the product name 'Heartware HVAD Pump Implant Kit' and the serial number HW42843. The recall applies to the specific model REF MCS1705PU used for hemodynamic support in advanced heart failure patients.
- Brand
Heartware- Category
Medical device
What to do — step by step
Contact Heartware
Reach out to Heartware directly for guidance on the recall and next steps.
How this recall unfolded
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2072-2021 (May 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2072-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.