Events

Recall of Device Recall Cardioblate Gemini Surgical Ablation Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Cardiac Surgery Technologies.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45940
  • Event Risk Class
    Class 2
  • Event Number
    Z-0727-2008
  • Event Initiated Date
    2007-11-21
  • Event Date Posted
    2008-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66543
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • 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.
  • 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.

Device

Device Recall Cardioblate Gemini Surgical Ablation Device
  • Model / Serial
    Lot Numbers: J243, J547, J548 and J656
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of FL, IL, IN, LA, MI, PA, TN, TX, UT, and WI
  • Product Description
    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.
  • Manufacturer
    Medtronic Cardiac Surgery Technologies

Manufacturer

Medtronic Cardiac Surgery Technologies
  • Manufacturer Address
    Medtronic Cardiac Surgery Technologies, 7601 Northland Dr N, Minneapolis MN 55428-1088
  • Source
    USFDA