Heartware, Inc. Recall 88135
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.
Heartware, Inc. Recall 88135 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2072-2021 |
Event ID | 88135 |
Event 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. |
Product Type | Devices |
Distribution | International distribution to the country of Germany. |
Quantity | 1 unit |
Recall Reason | The pump has an impeller with a shroud height that did not meet the lower control limit. |
Device Classification | 20210721 |
Device Code Info | UDI: 00888707007139. Serial Number HW42843 |
Center Classification Date | 20210713 |
Recall Initiation Date | 20210528 |
Recalling Firm | Heartware, Inc. |
Initial Notification | Telephone |
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