Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Reported: June 3, 2020 Initiated: April 3, 2020 #Z-2056-2020
Product Description
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
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
- 2225 Units
- Distribution
- Worldwide Distribution
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104. Recalled by Heartware, Inc.. Units affected: 2225 Units.
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-2056-2020.
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