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 |
Product Classification |
Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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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
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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 |
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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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