HeartWare HVAD Pump Implant Kit Impeller Defect Recall
HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a confirmed manufacturing defect in a critical cardiac device, but no reported illnesses or injuries. Per the rubric, such risk-of-harm products without reported harm score as High.
Plain-English summary
This is a Class II recall by Heartware, Inc. for the HeartWare HVAD Pump Implant Kit (REF MCS1705PU), a ventricular assist device indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure. The device is used as a bridge to cardiac transplantation, for myocardial recovery support, or as destination therapy for patients not eligible for transplantation.
The recall was issued because the pump's impeller has a shroud height that does not meet the lower control limit specified in the device specifications. The affected unit (Serial Number HW42843) was distributed internationally to Germany.
Patients who have received this implant and healthcare providers should contact Heartware, Inc. for guidance on the appropriate course of action. Because this device is essential for cardiac support in patients with advanced heart failure, patients should not make changes to their device management without consulting their cardiac care team. Healthcare providers should verify whether they have received the affected device and work with the manufacturer on any necessary follow-up.
The recalled product
- 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…
- Manufacturer
- Heartware, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00888707007139. Serial Number HW42843
Distribution
Distribution scope not specified by the agency.
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