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.
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.
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.
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.
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.
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.
Check if your HVAD system has the affected catalog/model numbers listed in the recall notice.
No, the device itself is not affected. Only the instructions for use, patient manuals, and emergency responder guides are recalled due to documentation errors.
Check if your HVAD system has the catalog/model numbers listed in the recall notice, such as IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001, or pump implant kits models: 1103, MCS1705PU, 1104, 1104JP.
The recall is for documentation errors, not the device itself. There is no immediate risk to health as the device functions normally.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1110-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1110-2022 from Medtronic. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
