Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2465-2023 — 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, A1

U.S. FDA — Device Enforcement · United States · 2023-06-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2465-2023
Date of alert: 2023-06-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardiac Assist, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00876971

Reported risk: Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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