Events

Recall of Device Recall Guidant CONTAK RENEWAL 3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific CRM Corp.

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
    35525
  • Event Risk Class
    Class 2
  • Event Number
    Z-1288-06
  • Event Initiated Date
    2006-05-15
  • Event Date Posted
    2006-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46324
  • 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
    Cardiac resynchronization therapy defibrillators - Product Code NIK
  • Reason
    Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. if function of this low voltage capacitor is compromised, the battery may deplete prematurely.
  • Action
    An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion.

Device

Device Recall Guidant CONTAK RENEWAL 3
  • Model / Serial
    model H170, serial numbers: 509659, 509677, 509678,  509679, 509685, 509694, 509695, 509696, 509762, 509884,  509974, 510012   model H175, serial numbers: 512665, 512666, 512667, 512668, 512708, 512709, 512710, 512711, 512713, 512719,  512721, 512722, 512723, 512759, 512791, 512793, 513062,  513064, 513073, 513085, 513086, 513227   model H177, serial numbers: 506951, 506953, 506954,  506955, 506956, 506957, 506959, 506960, 506967, 506969,  506970, 506973, 506974, 507013, 507014, 507472   model H179, serial numbers: 508312, 508316, 508322,  508325, 508326, 508336, 508342, 508349, 508404
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates
  • Product Description
    Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA