Medtronic Perfusion Systems: Cardioblate CryoFlex Surgical Ablation Console

Is my product affected?

Cardioblate CryoFlex Surgical Ablation Console

• UPC 00763000014988
• UPC 00643169183834
• UPC 00613994867315
• UPC 00613994981516

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling seven Cardioblate CryoFlex Surgical Ablation Console units distributed in Illinois, Kansas, Utah, Australia, and South Korea. The consoles may experience intermittent electrical connectivity between the console and probe, which is the reason for the recall.

The affected devices include Model 65CS1 units with serials 10047, 10048, 10050, 1689, CSC-591, CSC055, and 10051, as well as one Model R65CS1 unit with serial RCSC-201. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is potential for intermittent electrical connectivity between the console and probe.

Details from the source

Reason for recall: There is potential for intermittent electrical connectivity between the console and probe. Distribution: Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea Quantity: 7 devices Lot/code info: 1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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