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.
This recall has been terminated (originally issued February 2, 2008).
- Recall Initiated
- November 21, 2007
- Posted
- February 2, 2008
- Terminated
- December 17, 2011
- Recall Number
- Z-0727-2008
- Quantity
- 28 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI
Lot / Code Info
Lot Numbers: J243, J547, J548 and J656
Root Cause
Nonconforming Material/Component
Action Taken
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.