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U.S. Department of Health and Human Services

Class 2 Device Recall Cardima Surgical Ablation Probe (SAP)

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  Class 2 Device Recall Cardima Surgical Ablation Probe (SAP) see related information
Date Initiated by Firm May 20, 2010
Date Posted September 27, 2010
Recall Status1 Terminated 3 on March 23, 2011
Recall Number Z-2581-2010
Recall Event ID 56046
510(K)Number K022008  K060715  
Product Classification Surgical device, for ablation of cardiac tissue - Product Code OCL
Product Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
Code Information Model number 01-242208
Recalling Firm/
Manufacturer		 Cardima Inc
47266 Benicia St
Fremont CA 94538-1372
For Additional Information Contact
510-354-0166
Manufacturer Reason
for Recall		 Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
FDA Determined
Cause 2		 Device Design
Action Cardima issued a Product Recall Notification dated May 18, 2010 to customers, identifying the affected product, the sterility issue, and the actions to be taken by the customer. Custormers are to quarantine and return the affected product to the firm. The firm will replace returned product as soon as it becomes available. Cardima Customer Service can be contacted at 800 354-0102.
Quantity in Commerce 28 units
Distribution Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OCL and Original Applicant = CARDIMA, INC.
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