Heartware HVAD Pump Outflow Graft recall
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Why was Heartware HVAD Pump Outflow Graft recalled?
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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 lots and serial numbers in distribution
- Product
- Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
- Recalling firm
- Heartware, Inc.
- Quantity
- 20147 devices
- Distribution
- Worldwide Distribution
- Recall date
- June 3, 2020
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)