1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Summary
The FDA issued a Class II for 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104 by Heartware, Inc.. Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under wh.
Details
Source
Device Recall
External ID
Z-0480-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Lot/Code Info: Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA
Quantity Affected: 6 units
Reason for Recall
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-31
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 197 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-0480-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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