Devices

Device Recall Boston Scientific Teligen

Model / Serial
Model E102, Serial numbers: 002673, 003415, 004433, 004856, 005108, 005677, 006215, 006309, 006321, 006641, 006766, 006771, 006787, 006799, 006815, 006819, 006937, 006946, 006960, 006969, 006970, 006979, 006985, 007011, 007051, 007125, 007219, 007706, 007713, 007730, 008173, 008459, 008541, 008617, 008759, 008822, 008832, 008972, 008998, 009055, 009068, 009079, 009102, 009117, 009151, 009182, 009224, 009345, 009379, 009723, 010141, 010167 and 010186 and Model E110, Serial numbers: 002872, 003458, 003681, 004229, 004300, 004979, 004989, 006517, 006935, 007106, 008280, 008356, 008591, 009837, 009865, 010026, 010341, 010365, 010393, 010413, 010508, 010510, 010533, 010555, 010581, 010596, 010694, 011538, 011578, 012363, 012373, 012571, 012712, 012785, 012809, 013015, 013024, 013759, 013885, 111500, 111570, 111584, 111599, 111610, 111661, 111664, 111700, 111703, 112637, 112716 and 113694.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
U.S. Distribution only (states of AZ, CA, CT, FL, GA, IA, IL, KY, MD, MO, NH, NJ, NY, OH, PA, SC, TN, TX, WI, and Washington D.C.) and Puerto Rico.
Product Description
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. || The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing.
Manufacturer
Boston Scientific CRM Corp
1 Event
- Recall of Device Recall Boston Scientific Teligen

Manufacturer

Boston Scientific CRM Corp

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

2 devices with a similar name

Learn more about the data here

Device Recall Boston Scientific TELIGEN ICD

Model / Serial
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution-USA (nationwide) including Guam and Puerto Ricoand the countries of Argentina, Aruba, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, Hong Kong, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Poland, Portugal, Saudi Arabia, Singapore, Si Lanka, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, UK, United Arab Republic, and Venezuela.
Product Description
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Manufacturer
Boston Scientific CRM Corp

Device Recall Boston Scientific TELIGEN

Model / Serial
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, Gabon, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Jordan, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
Product Description
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Manufacturer
Boston Scientific CRM Corp

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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