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?
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
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?
Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
- 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
- Quantity
- 9 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
- Recall date
- May 3, 2017
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)