Summary
The FDA issued a Class I for HeartWare HVAD Implant Kit, REF MCS1705PU by Heartware, Inc.. Reason: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher fre.
Details
Source
Device Recall
External ID
Z-2195-2021
Action Date
2021-08-18
Status
Ongoing
Category
device
Product Description
HeartWare HVAD Implant Kit, REF MCS1705PU
Lot/Code Info: GTIN: 00888707005715, 00888707007160, 00888707007139, 00888707005364, 00888707009041 All serial numbers
Quantity Affected: 439 units
Reason for Recall
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Distribution
Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-03
Company
Miami Lakes, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 183 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-2195-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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