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U.S. Department of Health and Human Services

Class 2 Device Recall Cardioblate CryoFlex, Surgical Ablation Probe

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 Class 2 Device Recall Cardioblate CryoFlex, Surgical Ablation Probesee related information
Date Initiated by FirmOctober 12, 2020
Create DateNovember 25, 2020
Recall Status1 Terminated 3 on August 16, 2024
Recall NumberZ-0494-2021
Recall Event ID 86666
510(K)NumberK123733 
Product Classification Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue - Product Code OCL
ProductCardioblate 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.
Code Information Model Number 60SF3, GTIN 00763000114626 Serial Numbers: 17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027, 17420028, 17420029, 18420000, 18420001, 18420002, 18420003, 18420004, 18420015, 18420016, 18420021, 18420022, 18420023, 18420024, 18420025, 18420026, 18420027, 19820016, 19820017, 19820018, 19820019, 19820020, 19820021, 19820022, 19820023, 19820024, 21020005, 22320038, 22320040, 22320041, 22320042, 22320043, 22320044  
FEI Number 3008592544
Recalling Firm/
Manufacturer		 MEDTRONIC ATS MEDICAL, INC.
3800 Annapolis Ln N
Plymouth MN 55447-5439
For Additional Information ContactMedtronic 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
ActionIn 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 Commerce57 units
DistributionWorldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.
Total Product Life CycleTPLC Device Report
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OCL
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