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

Recall Z-0496-2021 — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

U.S. FDA — Device Enforcement · United States · 2020-10-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0496-2021
Date of alert: 2020-10-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: MEDTRONIC ATS MEDICAL, INC.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00763000114640

Reported risk: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

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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