HeartWare Ventricular Assist System: HeartWare Battery recall
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product…
Why was HeartWare Ventricular Assist System: HeartWare Battery recalled?
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers ranging BAT000001 to BAT199999.
- Product
- HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product…
- Recalling firm
- Heartware, Inc.
- Quantity
- 18, 631
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.
- Recall date
- July 20, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)