Events

Recall of Device Recall EZ Steer ThermoCool Nav

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosense Webster, Inc..

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
    60577
  • Event Risk Class
    Class 2
  • Event Number
    Z-0982-2012
  • Event Initiated Date
    2010-11-22
  • Event Date Posted
    2012-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106360
  • 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
    Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
  • Reason
    Biosense webster, inc. has recently become aware of the omission of the following two warning and precaution statements on the instructions for use (ifu) for the above catheter: 1. if phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. to minimize risk of atrio-esophageal fist.
  • Action
    Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information. For questions regarding this recall call 909-839-8604.

Device

Device Recall EZ Steer ThermoCool Nav
  • Model / Serial
    Lot Numbers: 15221536M, 15215004M, 15215001M, 15215000M, 15208579M, 15208577M, 15208574M, 14069262A, 14069168A, 14069084A, 15164269, 15164264, 15159917, 15159912, 15156608, 15148849, 15144223, 15128115, 15128113, 15119884, 15119883, 15116509, 15116506, 15103250, 15098193, 15098191, 15098190, 15095199, 15083389, 15083386, 15080818, 15080815, 15070703, 15067809, 15064960, 15032155, 15014525, 15014522, 15014521, 15010028, 15010027, 15007251, 15007250, 14152525, 14149131, 14149130, 14149129, 14146082, 14142307, 14138855, 14138853, 14138846, 14138795, 14120030, 14117394, 14117388, 14117385, 14117376, 14117371, 14117370, 14117356, 14113251, 14113249, 14109218, 14109216, 14102071, 14102068, 14097083, 14095220, 14093166, 14092574, 14091435, 14089642, 14089641, 14088995, 14087721, 14080304, 14080303, 14080302, 14079405, 14078387, 14078385, 14077789, 14075460, 14075459, 14071639, 14071638, 14071542, 14070108, 14068526, 14067399, 14065778, 14065064, 14065059, 14064262, 14064259, 14064258, 14063230, 14062655, 14062654, 14062652, 14062651, 14062042, 14062040, 14062039, 14062038, 14061249, 14060315, 14060311, 14058856, 14058855, 14057214, 14056275, 14056273, 14056272, 14053738, 14053167, 14052547, 14052249, 14051584, 14043263, 14042518, 14042517, 14038851, 14036716, 14036583, and 14036582
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. || The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA