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.
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.
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.
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.
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.
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.
Review your pump kit's model number and serial numbers against the list provided in the recall notice to determine if it is affected.
No action is required if your pump kit is not listed in the recall notice.
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.
Compare your pump kit's model number and serial numbers with the specific list of affected models and serial ranges provided in the recall notice.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-0946-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-0946-2021 from Heartware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
