LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note:
FDA device recall Z-2465-2023 · posted 2023-08-25 · Open, Classified
Recall details
- Recalling firm
- Cardiac Assist, Inc
- Reason for recall
- Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KFM
- Quantity affected
- 2 units
- Distribution
- US Nationwide distribution in the states of IL, FL.
- Date initiated
- 2023-06-30
- Date posted
- 2023-08-25
- Location
- Pittsburgh, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LifeSPARC Pump, LifeSPARC Controller (K183623) | Cardiacassist, Inc. | 2019-07-09 |