HeartWare Ventricular Assist System recall
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break…
Why was HeartWare Ventricular Assist System recalled?
Failures of the splice repair kit if exposed to excessive force.
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?
Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816
- Product
- HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break…
- Recalling firm
- HeartWare Inc
- Quantity
- 35
- Distribution
- Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.
- Recall date
- May 20, 2015
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)