Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects
Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 describes a potential defect in packaging seals without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic ATS Medical, Inc. is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe, Model Number 60SF2. The recall is due to a potential defect in the seals of the sterile barrier pouch used to package the 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 affected have serial numbers ranging from 18920030 to 18920055 and 20420030 to 20420051, with GTIN 00763000114619.
The products were distributed worldwide, including the United States, Belgium, Czech Republic, Germany, and Korea. Healthcare providers should stop using the affected probes and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: 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…
- Manufacturer
- MEDTRONIC ATS MEDICAL, INC.
- Affected units
- 37
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 60SF2
- GTIN 00763000114619
- Serial Numbers: 18920030
- 18920031
- 18920032
- 18920033
- 18920034
- 18920035
- 18920036
- 18920037
- 18920038
- 18920039
- 18920040
- 18920041
- 18920043
- 18920045
- 18920046
- 18920047
- 18920048
- 18920049
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 Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects
FDA (Devices) · 2020-12-02
- ModerateMedtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
FDA (Devices) · 2020-12-02
- ModerateMedtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
FDA (Devices) · 2020-12-02
- ModerateMedtronic Open Pivot Aortic Valve Graft Box Labeling Error Recall
FDA (Devices) · 2020-04-01
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