Z-0727-2008

Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two...

Name: Z-0727-2008 Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two...
Creator: Medtronic Cardiac Surgery Technologies
Published: 2007-11-21
License: https://open.fda.gov/license/

Medtronic Cardiac Surgery Technologies / initiated 2007-11-21 / Terminated / root cause: manufacturing process

FDA source

Medtronic Cardiac Surgery Technologies began a recall of Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw curvatures are provided: a standard... on 2007-11-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0727-2008
Status: Terminated
Initiated: 2007-11-21
Posted: 2008-02-02
Terminated: 2011-12-17
Recalling firm: Medtronic Cardiac Surgery Technologies
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 28 units
Distribution: Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI
Product codes and lots: Lot Numbers: J243, J547, J548 and J656

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)