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U.S. Department of Health and Human Services

Class 2 Device Recall Cardioblate Gemini Surgical Ablation Device

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  Class 2 Device Recall Cardioblate Gemini Surgical Ablation Device see related information
Date Initiated by Firm November 21, 2007
Date Posted February 02, 2008
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-0727-2008
Recall Event ID 45940
510(K)Number K0700311  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw curvatures are provided: a standard curve (model 49260) and extra curve (Model 49261). The device is intended for intermittent operation. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604.
Code Information Lot Numbers: J243, J547, J548 and J656
Recalling Firm/
Manufacturer		 Medtronic Cardiac Surgery Technologies
7601 Northland Dr N
Minneapolis MN 55428-1088
For Additional Information Contact
763-514-4000
Manufacturer Reason
for Recall		 Mechanism failure: Medtronic has identified an issue with four lots of the Cardioblate Gemini-s Surgical Ablation Devices in which the polycarbonate distal coil retainer can fail during the course of a procedure, potentially resulting in an inability to apply the necessary jaw closure force.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Certified letters were sent on 11/21/07 to Consignees. The letter identifies the issue with the device and requests that customers return the device back to the firm. Customers will be requested to complete a Field Correction Action certificate acknowledging the receipt of the information. For additional information you can contact a Medtronic Sales Representative at 763-391-9167.
Quantity in Commerce 28 units
Distribution Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI
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.
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