Heartware, Inc. Recall 88541
Description: Medtronic HVAD Pump Implant Kits
Heartware, Inc. Recall 88541 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2478-2021 |
| Event ID | 88541 |
| Event Description | Medtronic HVAD Pump Implant Kits |
| Product Type | Devices |
| Distribution | Distribution throughout the US. Also distribution in ARGENTINA Armenia, Australia, Austria, BELGIUM, BRAZIL, CANADA, CHILE, Colombia, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, Germany, GREECE HONG KONG, HUNGARY, INDIA, ISRAEL, Italy, JAPAN, Kazakhstan, Korea, KUWAIT, Latvia, LEBANON, LITHUANIA, LUXEMBOURG, Macedonia, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, Poland, ROMANIA, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab Emirates, United Kingdom, VIETNAM |
| Quantity | 11851 (potentially active, US); 1995 (active, US) |
| Recall Reason | There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair. |
| Device Classification | 20210922 |
| Device Code Info | Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers |
| Center Classification Date | 20210916 |
| Recall Initiation Date | 20210806 |
| Recalling Firm | Heartware, Inc. |
| Initial Notification | Letter |
| Similar To |