Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
Medtronic is recalling 15 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 hazard involves a potential defect in sterile packaging seals. This represents a risk of contamination or loss of sterility, which is a moderate risk without reported injuries or deaths.
Plain-English summary
Medtronic ATS Medical, Inc. is recalling 15 units of the Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7. The recall is due to a potential defect in the seals of the sterile barrier pouch used to package the 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 specific units involved have serial numbers ranging from 17720000 to 17720021 and 20620000.
The recall covers worldwide distribution, including the United States, Belgium, the Czech Republic, Germany, and Korea. Healthcare providers and facilities should stop using the affected units and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 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.
- Affected units
- 15
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 (17)
- Model Number 60SF7
- GTIN 00763000114633
- Serial Numbers: 17720000
- 17720001
- 17720002
- 17720011
- 17720012
- 17720013
- 17720014
- 17720015
- 17720016
- 17720017
- 17720018
- 17720019
- 17720020
- 17720021
- 20620000
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
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