Recall Z-2465-2023 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cardiac Assist, Inc
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17
| Date | Aug 25, 2023 (initiated Jun 30, 2023) |
| Status | Open, Classified |
| Reason | Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure, |
| Root cause | Under Investigation by firm |
| Action | LivaNova - TandemLife made Initial contact by phone/email on June 30,2023 to ensure the affected pumps were quarantined and not used. Other details of the recall, including how the customer is to respond, are included in the customer letter issued July 14, 2023 provided via regular mail and/or email. Letter states reason for recall, health risk and action taken. For questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of IL, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183623 | LifeSPARC Pump, LifeSPARC Controller Cardiacassist, Inc., Jul 9, 2019 |