Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Reported: June 3, 2020 Initiated: April 3, 2020 #Z-2058-2020
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.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 20147 devices
- Distribution
- Worldwide Distribution
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125. Recalled by Heartware, Inc.. Units affected: 20147 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Critical. Recall number: Z-2058-2020.
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