Heartware, Inc. Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model
Brand
Heartware, Inc.
Lot Codes / Batch Numbers
All serial numbers
Products Sold
All serial numbers
Heartware, Inc. is recalling Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system componen due to Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604
Recommended Action
Per FDA guidance
The firm, Medtronic, sent an "Urgent Medical Device Notice" dated Feb-2021 beginning 26-Feb-2021, UPS 2-day delivery, to its consignees who Medtronic records indicate they have received affected product. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: " Please review the updated IFU and PM steps as included in Appendix A.2 and share with patients as needed. " This notice must be shared with all those who need to be aware within your organization or to any organization where potentially affected patients have been transferred. " Please complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. If you have questions regarding this material, please contact your Medtronic Field Representative or Sr. Customer Quality Director, at 763-526-8583, email: rs.cvgrecalls@medtronic.com or Customer Quality at megan.e.ties@medtronic.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026