Recall Z-1426-2021 ยท DSQ Ventricular (Assist) Bypass
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, 1430
| Date | Feb 26, 2021 |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 23123 devices (11292 US) |
| Distribution | Worldwide distribution: US (nationwide) and countries of: ARGENTINA, Armenia, Australia, AUSTRIA, Bahrain, BELGIUM, Brazil, CANADA, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, FINLAND, France, GERMANY, Greece, Hong Kong, Hungary, INDIA, Israel, Italy, Japan, Kazakhstan, Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.