Recall Z-2072-2021— Heartware, Inc.
Class II · Ongoing
Class II FDA medical device recall by Heartware, Inc., initiated 2021-05-28. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.. Reason: The pump has an impeller with a shroud height that did not meet the lower control limit..
- Recalling firm
- Heartware, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-05-28
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Reason for recall
The pump has an impeller with a shroud height that did not meet the lower control limit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.