Z-2058-2020 Class I Ongoing
FDA device recall Z-2058-2020 was initiated by Heartware, Inc. on April 3, 2020 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: 20147 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 3, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20147 devices
Product Description
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution
Code Information
All lots and serial numbers in distribution