HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of
FDA device recall Z-1751-2015 · posted 2015-06-10 · Open, Classified
Recall details
- Recalling firm
- HeartWare Inc
- Reason for recall
- Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- DSQ
- Quantity affected
- 3,747 currently in use
- Distribution
- AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA, Foreign: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chi
- Date initiated
- 2015-04-29
- Date posted
- 2015-06-10
- Location
- Miami Lakes, FL
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