Medtronic Inc Recall 89966
Description: HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Medtronic Inc Recall 89966 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1207-2022 |
| Event ID | 89966 |
| Event Description | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan. |
| Quantity | 21 pump implant kits |
| Recall 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. |
| Device Classification | 20220615 |
| Device Code Info | a) Model Number 1104JP: GTIN: 00763000170967 Serial numbers: HW41784, HW41825, HW41829, HW41849, HW41852, HW41853, HW41863, HW42312, HW42352, HW42775, HW42818, HW42879, HW42882, and HW42884. b) Model Number MCS1705PU: GTIN 00888707005364, Serial Numbers: HW42448 and HW42571; GTIN 00888707007139, Serial Numbers: HW42955 and HW42962; GTIN 00888707009041, Serial Numbers HW43483 and HW43484; and GTIN 00888707003070, Serial number HW42153. |
| Center Classification Date | 20220603 |
| Recall Initiation Date | 20220414 |
| Recalling Firm | Medtronic Inc |
| Initial Notification | Letter |
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