Events

Recall of CONTAK RENEWAL 3

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

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
    33716
  • Event Risk Class
    Class 3
  • Event Number
    Z-0890-06
  • Event Date Posted
    2006-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42339
  • 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
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
  • Reason
    Devices manufactured with batteries built on april 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.
  • Action
    Guidant issued a Physicain letter, dated 10/25/05 to implanting/following physicians. The letter states the issues and reommends patient follow-up care every three months, as stated in published labeling. An Advisory Update, dated 12/20/05, was sent to physicians that describes the issue, states that here have been zero reports of battery weld failures on implanted devices and the results of laboratory testing (accelerated testing) in which they tried to induce the failure. The results of the testing induced 2 battery weld post failures. A projected rate of occurence was also given. Patient management recommendations have not changed.

Device

CONTAK RENEWAL 3
  • Model / Serial
    Model H170, serial numbers: 360449, 360632, 360655, 360657, 360661, 360666, 360714, 360719, 360721, 360738,  360741, 360742, 360743, 360745, 360746, 360749, 360756,  360758, 360763, 360766, 360790, 360791, 360792, 360796,  360800, 360802, 360844, 360847, 360848, 360861, 360863,  360904, 360907, 360908, 360910, 360986, 360987, 360988,  360989, 360991.  Model H175 serial numbers: 310338, 310434, 310523, 310532, 310533, 310537, 310544, 310545, 310706, 310707,  310709, 310713, 310719, 310721, 310734, 310735, 310737,  310746, 310753, 310796, 310798, 310813, 310907, 310908,  310909, 310913, 310916, 310976, 310990, 310996, 311007,  311010, 311011, 311013, 311015, 311016, 311092, 311096,  311152, 311154, 311181, 311185, 311386, 311389.   Model H177, serial numbers: 280992, 281011, 281012, 281017, 281020, 281021, 281022, 281024, 281045, 281056,  281066, 28107, 281077, 281119, 281121, 281123, 281124,  281126, 281127, 281143, 281175, 281213, 281233, 281247,  281320, 281356, 281364, 281368, 281371, 281376, 281385,  281401, 281403, 281413, 281476, 281480, 281484, 281485,  281491, 281533, 281539, 281542, 281544, 281559, 281562,  281580.   Model H179, serial numbers: 110905, 110907, 110908, 110950, 110952, 110954, 110955, 110958, 110980, 110983,  110987, 110988, 111000, 111001, 111003, 111004, 111007,  111012, 111024, 111041, 111042, 111128, 111173, 111180,  111198, 111201, 111248, 111250, 111254, 111263, 111294,  111299, 111308, 111313, 111334, 111335, 111336, 111338,  111340, 111341, 111342, 111346, 111350, 111352, 111390,  111391, 111392, 111393, 111397, 111422.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide (AL, AZ, CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI). OUS to include: Australia, France, Germany, India, Ireland, Israel, Italy, Netherlands, Norway, South Africa, Spain, Switzerland, Turkey, United Kingdom.
  • Product Description
    CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Manufacturer Address
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA