Heartware Medtronic HVAD Pump Implant Kits: Pumps May Fail to Start or Restart
Heartware recalls Medtronic HVAD Pump Implant Kits with specific model numbers and serial ranges due to pumps failing to start or restart properly. Affected units include models 1100-1205 and specific serial numbers. No immediate action is required for safe use but may need monitoring.
Lower-risk recall
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
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What happened, in plain English
Heartware is recalling Medtronic HVAD Pump Implant Kits labeled as models 1100-1205 with specific serial numbers. The pumps may fail to start, restart, or experience delays in restarting, which could lead to improper function. This does not cause immediate injury but requires monitoring. Read more at govinfonow.com/recall/63838-heartware-medtronic-hvad-pump-implant-kits-pumps-may-fail-to.
Source Summary by GovInfoNow · govinfonow.com/recall/63838-heartware-medtronic-hvad-pump-implant-kits-pumps-may-fail-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0946-2021
Cite this page
“Heartware Medtronic HVAD Pump Implant Kits: Pumps May Fail to Start or Restart.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63838-heartware-medtronic-hvad-pump-implant-kits-pumps-may-fail-to. Based on FDA recall #Z-0946-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0946-2021%22&limit=1).
Why it’s dangerous
Pumps manufactured with impellers from a subset of lots from a single supplier may fail to start, restart, or experience delays in restarting beyond normal expectations. This could lead to improper pump function but does not cause immediate injury.
Who’s affected
Patients with implanted Medtronic HVAD pumps who own the recalled model kits are most at risk. The issue affects specific model numbers and serial ranges, not all pumps.
How to tell if you have this one
Check if your pump kit has model numbers 1100-1205 and the listed serial numbers or GTINs. The recall includes specific model labels and serial ranges provided in the official notice.
- Brand
Heartware- Product
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101- Category
Medical device
What to do — step by step
Check Your Pump Kit
Review your pump kit's model number and serial numbers against the list provided in the recall notice to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide” 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 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Can this issue cause injury?
The recall states the pumps may fail to start or restart, but it does not indicate a risk of injury. The hazard is limited to pump functionality.
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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-0946-2021 (November 19, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0946-2021 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.