Recall Z-0495-2021 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
MEDTRONIC ATS MEDICAL, INC.
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 ablation segment.
| Date | Oct 12, 2020 |
| Status | Terminated |
| Reason | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| Root cause | Under Investigation by firm |
| Action | In the United States (US), beginning 29-Oct-2020, a written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. The letter requests the following actions: - Identify and quarantine all unused CryoFlex Surgical Ablation devices as listed in the table below. - Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-85 |
| Quantity | 15 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM Medtronic, Inc., Apr 1, 2013 |