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U.S. Department of Health and Human Services

Class 2 Device Recall Cardioblate CryoFlex

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 Class 2 Device Recall Cardioblate CryoFlexsee related information
Date Initiated by FirmSeptember 27, 2021
Create DateNovember 19, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0273-2022
Recall Event ID 88845
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 Console
Code Information 1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516)
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact
763-391-9000
Manufacturer Reason
for Recall		There is potential for intermittent electrical connectivity between the console and probe.
FDA Determined
Cause 2		Process control
ActionIn the United States (US), beginning 27-SEP-2021 Medtronic initiated communications of an Urgent Medical Device Correction letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Outside of the United States (OUS), beginning 27-SEP-2021, a written Urgent Medical Device Correction letter is being delivered via regionally approved methods to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Correction notification and follow the Recommended Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.
Quantity in Commerce7 devices
DistributionDistribution in US - IL, KS, and UT Distribution outside of US to Australia and South 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OCL
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