Heart Ware(TM) HVAD(TM) System Controller/Controller recall
Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated…
Why was Heart Ware(TM) HVAD(TM) System Controller/Controller recalled?
Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
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 number range: CON300175 - CON320540
- Product
- Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated…
- Recalling firm
- Heartware, Inc.
- Quantity
- 17,275 units
- Distribution
- Worldwide Distribution
- Recall date
- October 10, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)