HeartWare recall
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left…
Why was HeartWare recalled?
The pump has an impeller with a shroud height that did not meet the lower control limit.
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?
UDI: 00888707007139. Serial Number HW42843
- Product
- HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left…
- Recalling firm
- Heartware, Inc.
- Quantity
- 1 unit
- Distribution
- International distribution to the country of Germany.
- Recall date
- July 21, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)