Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.
Plain-English summary
Medtronic ATS Medical, Inc. is recalling 57 units of the Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3. The recall is due to a potential defect in the seals of the sterile barrier pouch used to package these disposable devices.
The affected probes are single-use, disposable cryoprobes designed for use with the CryoFlex Surgical Ablation System. They feature an integrated thermocouple for monitoring temperature at the ablation segment. The distribution pattern includes US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, and Korea.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 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
- Manufacturer
- MEDTRONIC ATS MEDICAL, INC.
- Hazard
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number 60SF3
- GTIN 00763000114626 Serial Numbers: 17420000
- 17420001
- 17420002
- 17420003
- 17420004
- 17420005
- 17420006
- 17420007
- 17420008
- 17420009
- 17420010
- 17420013
- 17420014
- 17420015
- 17420016
- 17420017
- 17420018
- 17420019
- 17420020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by MEDTRONIC ATS MEDICAL, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · MEDTRONIC ATS MEDICAL, INC.
See all →- ModerateMedtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects
FDA (Devices) · 2020-12-02
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