Heartware recalls Medtronic HVAD Pump Implant Kits (product numbers 1100-1104JP, 1205, MCS1705PU) due to potential driveline repair complications during controller exchanges.
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 is recalling Medtronic HVAD Pump Implant Kits that could cause difficulty accessing the driveline connector during controller exchanges if a strain relief repair is improperly handled. This risk may lead to compromised repairs or failed maintenance.
The driveline cover may not slide back properly after a strain relief repair, making it difficult to access the connector during controller exchanges. Sliding the cover over a repair could also damage the repair itself.
Patients with Medtronic HVAD pump implants using the recalled product numbers (1100-1104JP, 1205, MCS1705PU) are affected. Patients undergoing regular pump maintenance or controller exchanges are most at risk.
Check your Medtronic HVAD Pump Implant Kit serial number against the product numbers listed: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU.
Compare your serial number with the listed product numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU.
Product numbers 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU.
The driveline cover may not slide back properly after a strain relief repair, potentially causing difficulty accessing the connector during controller exchanges or damaging the repair.
No, the recall does not require immediate stop use. Patients should check their serial number and follow the provided steps.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2478-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2478-2021 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.
