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

Recall Z-1763-2022 — TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

U.S. FDA — Device Enforcement · United States · 2022-07-21 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1763-2022
Date of alert: 2022-07-21
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Cardiac Assist, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00814112020562

Reported risk: Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.

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.

Recall Z-1763-2022 — TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

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