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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 Recall
Cardioblate Gemini Surgical Ablation Device
see related information
Date Posted February 02, 2008
Recall Status1 Open
Recall Number Z-0727-2008
Recall Event ID 45940
Premarket Notification
510(K) Number
K070031 
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, Minnesota 55428-1088
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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 = GEI and Original Applicant = MEMOMETAL TECHNOLOGIES
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