HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monit
Summary
The FDA issued a Class II for HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b by Heartware, Inc.. Reason: Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx.
Details
Source
Device Recall
External ID
Z-1993-2023
Action Date
2023-06-28
Status
Ongoing
Category
device
Product Description
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Lot/Code Info: a) Model Number 1521US, GTIN 00888707009256, Serial/Lot Numbers: MON500010, MON500012, MON500016, MON500028, MON500026, MON500005, MON500006, MON500007. b) Model Number 1521GB, GTIN 00888707006521, Serial/Lot Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061. c) Model Number 1521IL, GTIN 00888707010108, Serial/Lot Number: MON400017. d) Model Number 1521DE, GTIN 00888707010085, Serial/Lot Numbers: MON400045, MON400021, MON400013.
Quantity Affected: 19 units
Reason for Recall
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
Distribution
Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-16
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 246 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-1993-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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