Cardioblate CryoFlex Surgical Ablation Console recall
Cardioblate CryoFlex Surgical Ablation Console
Why was Cardioblate CryoFlex Surgical Ablation Console recalled?
There is potential for intermittent electrical connectivity between the console and probe.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- Cardioblate CryoFlex Surgical Ablation Console
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 7 devices
- Distribution
- Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
- Recall date
- December 1, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)