Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 2, 2020
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 its ablation segment.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Ats Medical, INC. recalled Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 1… - a moderate-severity action.
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 1… was recalled by Medtronic Ats Medical, INC. in December 2, 2020. Reason: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposable…. Check the official notice for the remedy. Verify recall #Z-0494-2021 with the FDA Devices before acting.
The recall
Medtronic Ats Medical, INC. issued this moderate-severity FDA Devices recall-There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposable….
- Moderate
- severity level
- 57 units
- affected scope
- Class II
- classification
- December 2, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0494-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0494-2021) was formally reported on December 2, 2020, with the manufacturer initiating the action on October 12, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Ats Medical, INC. is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 57 units.
The documented reason for this recall is: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
57 units
Related Recalls
6
0 from same agency
Product description
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 its ablation segment.
Reason for recall
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0494-2021 |
| Date reported | December 2, 2020 |
| Date initiated | October 12, 2020 |
| Recalling firm | Medtronic Ats Medical, INC. |
| Firm location | Plymouth, MN |
| Affected scope | 57 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0494-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 its ablation segment.. Recalled by Medtronic Ats Medical, INC.. Units affected: 57 units.
Why was this product recalled? ▼
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0494-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0494-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported December 2, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.