LifeSPARC recallZ-2465-2023 · Cardiac Assist, Inc · initiated Jun 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardiac Assist, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-2465-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2023
- Posted by the FDA
- Aug 25, 2023
- Recalling firm
- Cardiac Assist, Inc
- Quantity
- 2 units
- Product code
- KFM
- FDA submissions
- K183623
- Distribution
- US Nationwide distribution in the states of IL, FL.
Product description
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
Code information (models, lots, serial numbers)
S/N and UDI: (1)Kit 5830-2916 Pump SN 00876971 UDI: ( 01)00814112020609(11)230411(17)250219(21)00876971 (2)Kit 5840-2417 Pump SN 00876972 UDI: (01)00814112020609(11)230411(17)250219(21)00876972
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LifeSPARC 5800-1000Cardiacassist, Inc. · Accessory Equipment, Cardiopulmonary Bypass1 recall1 death9 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K183623 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LifeSPARC 5900-0001Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls1 death5 reports
- LifeSPARC 5900-0000Cardiacassist, Inc. · Control, Pump Speed, Cardiopulmonary Bypass2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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