Device recall

Z-0273-2022: Cardioblate CryoFlex Surgical Ablation Console

FDA device recall · Class II · Medtronic Perfusion Systems

Key facts

Recall number (Z-number) Z-0273-2022
Recall event 88845
Product Cardioblate CryoFlex Surgical Ablation Console
Product code OCL
Recalling firm Medtronic Perfusion Systems
Recall class Class II
Status Open, Classified
510(k) numbers K123733
FEI number 1000116158

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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