There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
“Heartware Medtronic HVAD Pump Implant Kits Recall: Driveline Repair Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62032-heartware-medtronic-hvad-pump-implant-kits-recall-driveline-repair-risk. Based on FDA recall #Z-2478-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2478-2021%22&limit=1).
The FDA announced on Aug. 6, 2021, that Heartware, Inc. is recalling Medtronic HVAD Pump Implant Kits due to potential driveline cover issues. The agency issued recall number Z-2478-2021 for the Class II device.
Units affected: 11,851 potentially active in the US; 1,995 active in the US
The hazard
According to the FDA, more force is required to slide the driveline cover away from the connector after a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty accessing the Driveline connector during a controller exchange and may compromise the repair.
Context
GovInfoNow's records show Heartware, Inc. has 17 other recalls on record since Aug. 28, 2018. Other recent recalls of similar products include Medline Medical Kits Recall: Risk of Syringe Connection Disconnection (Feb. 27, 2026), Medline Medical Kits Recall: Risk of Syringe Disconnection During Use (Feb. 27, 2026), and Medline medical convenience kits recall: Risk of syringe rotating adaptor unwinding during use (Feb. 27, 2026).
How to tell if you have this one
Check your Medtronic HVAD Pump Implant Kit serial number against the product numbers listed: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU.
Brand
Heartware
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Serial Number
Compare your serial number with the listed product numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution throughout the US. Also distribution in ARGENTINA Armenia, Australia, Austria, BELGIUM, BRAZIL, CANADA, CHILE, Colombia, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, Germany, GREECE HONG KONG, HUNGARY,…” 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 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-2478-2021 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2478-2021 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.