Cardioblate CryoFlex recallZ-0273-2022 · Medtronic Perfusion Systems · initiated Sep 27, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is potential for intermittent electrical connectivity between the console and probe.
FDA root cause category: Process control
What the company is doing
In the United States (US), beginning 27-SEP-2021 Medtronic initiated communications of an Urgent Medical Device Correction letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Outside of the United States (OUS), beginning 27-SEP-2021, a written Urgent Medical Device Correction letter is being delivered via regionally approved methods to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Correction notification and follow the Recommended Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.
Recall details
- Recall number
- Z-0273-2022
- Status
- Open, Classified
- Initiated by the company
- Sep 27, 2021
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 7 devices
- Product code
- OCL
- FDA submissions
- K123733
- Distribution
- Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Product description
Cardioblate CryoFlex Surgical Ablation Console
Code information (models, lots, serial numbers)
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)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death11 reports
- Cardioblate® CryoFlex® 65CS1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 death6 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K123733 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Cardioblate® CryoFlex® 60SF3Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall7 deaths41 reports
- Cardioblate® CryoFlex® 60SF2Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall13 reports
- Cardioblate® CryoFlex® 60SF7Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall1 report
- Cardioblate® CryoFlex® 60CM1Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 recall0 reports
- Cardioblate® CryoFlex® 60SF2Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue4 reports
- Cardioblate® CryoFlex® 60SF3Medtronic, Inc. · Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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