Events

Recall of Cooltip RFA Electrode Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett Inc. (dba Covidien LP).

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
    62705
  • Event Risk Class
    Class 2
  • Event Number
    Z-2301-2012
  • Event Initiated Date
    2012-08-01
  • Event Date Posted
    2012-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111480
  • 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
    Covidien is conducting a recall of various production lots of dghp rfa high power single use grounding pads and cool-tip rfa electrode kits due to the potential for foil degradation on the dgp-hp single use grounding pad which may result in an electrical burn to the patient at the application site.
  • Action
    The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 6, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine and discontinue use of the device; immediately advise all DGPHP RFA High-Power single use grounding pads and Cool-tip RF Electrode kit users of this recall; complete and return the attached Recalled Product Return Form in its entirety via fax to (800) 895-6140; return affected product to Covidien Attn: Field Returns Department, 195 McDermott Road, North Haven, CT 06473; if purchased directly from Covidien include completed form via fax or by email to : feedback.customerservice@covidien.com; if purchased from distributor complete form and contact your Distributor directly (completed form and all affected units must be returned through the Distributor); and reply to Covidien WHETHER OR NOT you have affect product at your site. If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance, Monday through Friday, 8:30-5:00, directly at 203-492-5232.

Device

Cooltip RFA Electrode Kits
  • Model / Serial
    ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through, 191407; ACT2020, 168854 through, 210720X; SWCT2303, 195745 through, 195745; ACT2030, 168574 through, 209453X; SWCT2530, 205456 through, 205456; ACT2530, 169684 through, 209599X; SWCT25303, 177906 through, 213729X; ACTC1025, 171300 through, 208194X; SWCT2540, 191404 through, 205455 DGPHP, 162732 through, 214867X.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
  • Product Description
    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) || The product is used during ablation surgical procedures.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • Manufacturer Address
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA