Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw
FDA device recall Z-0727-2008 · posted 2008-02-02 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiac Surgery Technologies
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 28 units
- Distribution
- Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI
- Date initiated
- 2007-11-21
- Date posted
- 2008-02-02
- Date terminated
- 2011-12-17
- Location
- Minneapolis, MN
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