Z-2195-2021Class I
HeartWare HVAD Implant Kit, REF MCS1705PU
HeartWare, Inc. / initiated 2021-06-03 / Open, Classified
Heartware, Inc. began a recall of HeartWare HVAD Implant Kit, REF MCS1705PU on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2195-2021
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- HeartWare, Inc.
- Product
- HeartWare HVAD Implant Kit, REF MCS1705PU
- Product code
- DSQ Ventricular (Assist) Bypass
- 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.
- FDA root cause
- Unknown/Undetermined by firm
- Action
- In the United States, beginning 03-Jun-2021, this notice was delivered to Risk Managers via UPS 2-day delivery in the United States as well as through verbal and in person follow ups from the Medtronic field staff. In addition, a courtesy copy was sent to all implanting and following physicians via UPS 2-day delivery. Finally, an e-mail notice was sent as a courtesy copy to all consignees who had opted into communication from Medtronic. Medtronic began an additional communication on 7 July 2021 to all consignees who, according to Medtronic records had unexpired product (see Attachment D Product List) at the time of the initial communication on 03-JUN-2021. The consignees are being asked to confirm receipt of the notification and return all affected product within their possession. This communication also stresses the importance of not returning peripherals (batteries, cables, patient packs, etc.) and surgical tool kits if they still have patients on support. In the US, this communication was delivered to VAD Coordinators via UPS 2-day delivery. Outside of the United States, beginning 07-JUL-2021 this communication will be delivered to consignees.
- Quantity in commerce
- 439 units
- 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.
- Product codes and lots
- GTIN: 00888707005715, 00888707007160, 00888707007139, 00888707005364, 00888707009041 All serial numbers
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2188-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2189-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2190-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2191-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2192-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2193-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2194-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2195-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2196-2021 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2197-2021 | Class I | Ongoing | Voluntary: Firm initiated |
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