Recall Z-2058-2020— Heartware, Inc.
Class I · Ongoing
Class I FDA medical device recall by Heartware, Inc., initiated 2020-04-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125. Reason: 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..
- Recalling firm
- Heartware, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2020-04-03
- Firm location
- Miami Lakes, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.