Medtronic HeartWare Ventricular Assist Device (HVAD) Instructions for Use Recall: Errors
Medtronic recalls instructions for use, patient manuals, and emergency responder guides for HeartWare Ventricular Assist Device (HVAD) systems due to errors and inconsistencies in documentation. Affected models include specific pump implant kits and catalog numbers.
Lower-risk recall
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
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What happened, in plain English
Medtronic is recalling instructions for use, patient manuals, and emergency responder guides for HeartWare Ventricular Assist Device (HVAD) systems because they contain errors and inconsistencies. This could lead to confusion during critical medical procedures. Affected units have specific model numbers and catalog codes. Read more at govinfonow.com/recall/60880-medtronic-heartware-ventricular-assist-device-hvad-instructions-for-use-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/60880-medtronic-heartware-ventricular-assist-device-hvad-instructions-for-use-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1110-2022
Cite this page
“Medtronic HeartWare Ventricular Assist Device (HVAD) Instructions for Use Recall: Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60880-medtronic-heartware-ventricular-assist-device-hvad-instructions-for-use-recall. Based on FDA recall #Z-1110-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1110-2022%22&limit=1).
Why it’s dangerous
The instructions for use, patient manuals, and emergency responder guides contain errors and inconsistencies. This could cause confusion during critical medical procedures, but it does not affect the device's functionality or safety.
Who’s affected
Patients with HeartWare Ventricular Assist Devices (HVAD) and healthcare providers who use the system. The risk is low as the issue is with documentation, not the device itself.
How to tell if you have this one
Check if your HVAD system has the following catalog/model numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001. Also, check for specific pump implant kits models: 1103, MCS1705PU, 1104, 1104JP.
- Brand
Medtronic- Product
Medtronic Inc recalls Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD)- Category
Medical device
What to do — step by step
Review Documentation
Check if your HVAD system has the affected catalog/model numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 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.
Questions people ask
Is there a risk to my health from this recall?
The recall is for documentation errors, not the device itself. There is no immediate risk to health as the device functions normally.
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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-1110-2022 (March 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1110-2022 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.