Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0495-2021·Announced 2020-12-02

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.

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 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.
Category: Medical Device — Surgical Instrument
Hazard: sterility-compromise
packaging-defect
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 →

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