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U.S. Department of Health and Human Services

Class 1 Device Recall HeartWare HVAD System

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  Class 1 Device Recall HeartWare HVAD System see related information
Date Initiated by Firm February 26, 2021
Create Date April 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-1426-2021
Recall Event ID 87456
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
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 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.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Heartware, Inc.
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact MCS Customer Service
877-367-4823
Manufacturer 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
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
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