HeartWare Ventricular Assist System recall: Foreign Material
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a…
Why was HeartWare Ventricular Assist System recalled?
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
- Product
- HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a…
- Recalling firm
- HeartWare, Inc
- Quantity
- 344 pumps
- Distribution
- Worldwide 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.
- Recall date
- October 19, 2016
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)