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.
Reported: July 21, 2021 Initiated: May 28, 2021 #Z-2072-2021
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.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 1 unit
- Distribution
- International distribution to the country of Germany.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Heartware, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
The pump has an impeller with a shroud height that did not meet the lower control limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2072-2021.
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