[Recalled] 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 prob
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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 temperature at its abla |
|---|---|
| Brand / manufacturer | MEDTRONIC ATS MEDICAL, INC. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0493-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 October 2020 |
| EAN / barcode | 00763000114619 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.