Z-2192-2021 Class I Ongoing
FDA device recall Z-2192-2021 was initiated by Heartware, Inc. on June 3, 2021 and is designated Class I. 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 mortalit… The recall status is ongoing. Affected quantity: 338 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 3, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 338 units
Product Description
Reason for Recall
Distribution Pattern
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.