Serial number range 118626 - 243772 includes ICDs manufactured prior to November 13, 2002. This range includes all affected devices but may include some unaffected devices.
Worldwide. Including United States and countries such as: Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Polynesia, Portugal, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Uruguay, Venezuela
Description du dispositif
Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.
RENEWAL (model H135) serial number range 100027 - 999983 includes CRT-Ds manufactured on or before August 26, 2004. These ranges include all affected devices but may include some unaffected devices.
worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom and Venezuela.
Description du dispositif
CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.