UnratedMedical device recall · FDA · Published April 14, 2022
Medtronic HeartWare HVAD Pump Implant Kit Recall: Weld Defect Risk
Medtronic recalls HeartWare HVAD Pump Implant Kit models 1104JP and MCS1705PU due to suspected welding defects that could cause pump malfunction and affect blood flow.
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
Medtronic is recalling two specific HeartWare HVAD pump implant kits (model numbers 1104JP and MCS1705PU) because a welding defect might allow moisture to enter and corrode internal components, potentially disrupting blood flow. This could lead to symptoms similar to pump thrombosis, though the issue is under investigation. Read more at govinfonow.com/recall/60806-medtronic-heartware-hvad-pump-implant-kit-recall-weld-defect-risk.
“Medtronic HeartWare HVAD Pump Implant Kit Recall: Weld Defect Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60806-medtronic-heartware-hvad-pump-implant-kit-recall-weld-defect-risk. Based on FDA recall #Z-1207-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1207-2022%22&limit=1).
The FDA announced on April 14, 2022, that Medtronic Inc. is recalling HeartWare HVAD Pump Implant Kits due to a potential welding defect causing pump malfunction. Owners should contact Medtronic for information regarding the voluntary recall.
How to tell if you have it
HeartWare HVAD Pump Implant Kit, Model Number 1104JP
HeartWare HVAD Pump Implant Kit, Model Number MCS1705PU
UPC 00763000170967
UPC 00888707003070
UPC 00888707005364
UPC 00888707007139
UPC 00888707009041
The hazard
According to the FDA, the pump may have a welding defect that can lead to malfunction. The issue is suspected to allow moisture into the center post and corrode magnets, potentially affecting blood flow through the pump.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since September 10, 2017. Other recent recalls of similar products include Abiomed Heart Pump Kit Recall (June 11, 2026) and Medtronic Perfusion Systems EOPA Cannula Recall (June 24, 2026).
How to tell if you have this one
Check if your HeartWare HVAD pump implant kit has model number 1104JP with serial numbers listed or model number MCS1705PU with the specified GTINs and serial numbers.
Brand
Medtronic
Product
Medtronic Inc recalls HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify your pump model and serial numbers to see if they match the recalled items listed in the notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Delaware, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1207-2022 (April 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1207-2022 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.