Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0494-2021·Announced 2020-12-02

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.

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 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…
Manufacturer: MEDTRONIC ATS MEDICAL, INC.
Category: Medical Device — Surgical Instrument
Hazard: sterility-compromise
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 →

Same manufacturer · MEDTRONIC ATS MEDICAL, INC.

See all →

Moderate
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects
FDA (Devices) · 2020-12-02
Moderate
Medtronic Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects
FDA (Devices) · 2020-12-02
Moderate
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
FDA (Devices) · 2020-12-02
Moderate
Medtronic Open Pivot Aortic Valve Graft Box Labeling Error Recall
FDA (Devices) · 2020-04-01

Same hazard · sterility compromise