Date Initiated by Firm |
October 12, 2020 |
Create Date |
November 25, 2020 |
Recall Status1 |
Completed |
Recall Number |
Z-0496-2021 |
Recall Event ID |
86666 |
510(K)Number |
K123733
|
Product Classification |
Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue - Product Code OCL
|
Product |
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 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. |
Code Information |
Model Number 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002 |
Recalling Firm/ Manufacturer |
MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Ln N Plymouth MN 55447-5439
|
For Additional Information Contact |
Medtronic Customer Service 800-854-3570
|
Manufacturer Reason for Recall |
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
|
FDA Determined Cause 2 |
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 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return of this product.
- < Please complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. >
- Please forward this notice to all those who need to be aware within your organization. |
Quantity in Commerce |
3 units |
Distribution |
Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
|
510(K) Database |
510(K)s with Product Code = OCL and Original Applicant = MEDTRONIC INC.
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