Recall Z-1207-2022 ยท DSQ Ventricular (Assist) Bypass
Medtronic Inc
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
| Date | Apr 14, 2022 |
| Status | Open, Classified |
| Reason | The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis. |
| Root cause | Under Investigation by firm |
| Action | The firm issued letters flagged "Urgent Medical Device Recall" dated April 2022 on 4/14/2022 via 2-day UPS delivery. The letter provided the issue description and requested the consignee to take the following actions: Immediately quarantine and return the unused affected product, complete the enclosed Customer Confirmation Form and email it to the firm, share the notice with all those who need to be aware within their organization or to any organization where the existing product has been transferred, and retain the notification for their records regarding the retrieval of the unused affecte |
| Quantity | 21 pump implant kits |
| Distribution | Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.