Z-2465-2023Class II

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number...

Name: Z-2465-2023 LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number...
Creator: Cardiac Assist, Inc
Published: 2023-06-30
License: https://open.fda.gov/license/

Cardiac Assist, Inc / initiated 2023-06-30 / Open, Classified / root cause: manufacturing process

FDA source

Cardiac Assist, Inc began a recall of LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an... on 2023-06-30. FDA classified it as Class II and gives the reason as "Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2465-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-30
Posted: 2023-08-25
Recalling firm: Cardiac Assist, Inc
Product: 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
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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,
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of IL, FL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2465-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2465-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-25

Product code KFM

K183623Class IILifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. / cleared 2019-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)