Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA device recall Z-1323-2013 · posted 2013-05-14 · Terminated
Recall details
- Recalling firm
- Heartware Inc
- Reason for recall
- HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
- Action taken
- HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their customers on February 7, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. They were asked to sign and return the acknowledgement form to HeartWare. For questions contact your HeartWare representative or Customer Service at 1-877-367-4823.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DSQ
- Quantity affected
- 3,544
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland,
- Date initiated
- 2012-12-27
- Date posted
- 2013-05-14
- Date terminated
- 2013-07-09
- Location
- Miami Lakes, FL
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