Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall HeartWare HVAD Implant Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall HeartWare HVAD Implant Kitsee related information
Date Initiated by FirmJune 03, 2021
Create DateAugust 06, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2194-2021
Recall Event ID 88197
PMA NumberP100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
ProductHeartWare HVAD Implant Kit, REF 1104JP
Code Information GTIN: 00888707005838 All serial numbers
Recalling Firm/
Manufacturer		 Heartware, Inc.
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information ContactMCS Customer Service
877-367-4823
Manufacturer Reason
for Recall		Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionIn the United States, beginning 03-Jun-2021, this notice was delivered to Risk Managers via UPS 2-day delivery in the United States as well as through verbal and in person follow ups from the Medtronic field staff. In addition, a courtesy copy was sent to all implanting and following physicians via UPS 2-day delivery. Finally, an e-mail notice was sent as a courtesy copy to all consignees who had opted into communication from Medtronic. Medtronic began an additional communication on 7 July 2021 to all consignees who, according to Medtronic records had unexpired product (see Attachment D  Product List) at the time of the initial communication on 03-JUN-2021. The consignees are being asked to confirm receipt of the notification and return all affected product within their possession. This communication also stresses the importance of not returning peripherals (batteries, cables, patient packs, etc.) and surgical tool kits if they still have patients on support. In the US, this communication was delivered to VAD Coordinators via UPS 2-day delivery. Outside of the United States, beginning 07-JUL-2021 this communication will be delivered to consignees.
Quantity in Commerce63 units
DistributionWorldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = DSQ
-
-