HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with adva
Summary
The FDA issued a Class II for HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for h by Heartware, Inc.. Reason: The pump has an impeller with a shroud height that did not meet the lower control limit..
Details
Source
Device Recall
External ID
Z-2072-2021
Action Date
2021-07-21
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI: 00888707007139. Serial Number HW42843
Quantity Affected: 1 unit
Reason for Recall
The pump has an impeller with a shroud height that did not meet the lower control limit.
Distribution
International distribution to the country of Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-28
Company
Miami Lakes, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Heartware, Inc. has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heartware, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heartware, Inc. have FDA actions?
Heartware, Inc. has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2072-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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