Z-2059-2020 Class I Ongoing
FDA device recall Z-2059-2020 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: 560 units.
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
- 560 units
Product Description
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
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
GTIN 00888707000147, All lot numbers in distribution