Recall Z-0727-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Medtronic Cardiac Surgery Technologies
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.
| Date | Feb 2, 2008 (initiated Nov 21, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 28 units |
| Distribution | Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.