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 Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
This recall is currently active, issued February 26, 2021. It was issued by Heartware, Inc..
- Company
- Heartware, Inc.
- Recall Initiated
- February 26, 2021
- Recall Number
- Z-1426-2021
- Quantity
- 23123 devices (11292 US)
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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
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, Kuwait, Latvia, LEBANON, LITHUANIA, Luxembourg, Macedonia, Malaysia, NETHERLANDS, NEW ZEALAND, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA Spain, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab, Emirates, United Kingdom, and VIETNAM.
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
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.