Heartware HVAD Pump Implant accessories recall
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
Why was Heartware HVAD Pump Implant accessories 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?
GTIN 00888707000147, All lot numbers in distribution
- Product
- Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
- Recalling firm
- Heartware, Inc.
- Quantity
- 560 units
- Distribution
- Worldwide Distribution
- Recall date
- June 3, 2020
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)