Cardiac Assist, Inc: Medical Device Recall in 2023 - (Recall #: Z-2465-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 30, 2023

Date Posted: September 6, 2023

Recall Number: Z-2465-2023

Event ID: 92748

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,

Status: Ongoing

Product Quantity: 2 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of IL, FL.

Voluntary or Mandated:

Voluntary: Firm initiated