Medtronic Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects
Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect 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 illnesses, injuries, or specific contamination events, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic ATS Medical, Inc. is recalling three units of the Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1. These single-use, disposable cryoprobes are designed for use with the CryoFlex Surgical Ablation System and feature an integrated thermocouple for temperature monitoring.
The recall is being issued due to a potential defect in the seals of the sterile barrier pouch used to package the devices. The affected units have Serial Numbers 18920000, 18920001, and 18920002, and GTIN 00763000114640.
The devices were distributed worldwide, including across the United States and in Belgium, the Czech Republic, Germany, and Korea. Users should stop using the affected probes and contact Medtronic for further instructions.
The recalled product
- Product
- Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 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…
- Manufacturer
- MEDTRONIC ATS MEDICAL, INC.
- Affected units
- 3
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 (5)
- Model Number 60CM1
- GTIN 00763000114640
- Serial Numbers: 18920000
- 18920001
- 18920002
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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