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.
FDA Recall Z-0727-2008 · Posted 2008-02-02
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Recalling FirmMedtronic Cardiac Surgery Technologies
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-11-21
Date Terminated2011-12-17
Product Quantity28 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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