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U.S. Department of Health and Human Services

Class 1 Device Recall HeartWare Ventricular Assist System

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 Class 1 Device Recall HeartWare Ventricular Assist Systemsee related information
Date Initiated by FirmAugust 17, 2016
Create DateOctober 13, 2016
Recall Status1 Open3, Classified
Recall NumberZ-0006-2017
Recall Event ID 74999
PMA NumberP100047 
Product Classification Ventricular (assisst) bypass - Product Code DSQ
ProductHeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Code Information All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
Recalling Firm/
Manufacturer		 HeartWare, Inc
14400 NW 60th Ave
Miami Lakes FL 33014-2807
For Additional Information ContactKate Jacobson
305-364-1575
Manufacturer Reason
for Recall		Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
FDA Determined
Cause 2		Component design/selection
ActionHeartWare notified their customers with an Urgent Medical Device Recall notice on 8/17/2016 of the HVAD Pump, listing the US Product: Model No. 1103 and the International Product: Model No.: 1104. The letter discussed the reason for the recall as well as the risk to health. Customers were to identify affected product in their inventory; and, complete and return the acknowledgement form. Acknowledgement should be provided no later than 30 days from date of the letter either to the HeartWare representative; or, via e-mail to FSCA @Heartware.com; or, FAX the signed form to (305) 364-2665. Affected product should be returned upon receipt of replacement product; and, the completion form should also be completed and returned. Questions or concerns should be directed to a local HeartWare representative.
Quantity in Commerce344 pumps
DistributionWorldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
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
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