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Terminated

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110.

FDA Recall Z-1679-2009 · Posted 2009-07-14

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWP
Date Initiated2009-03-23
Date Terminated2012-10-18
Product Quantity49,148 total

Reason for Recall

Lead connection issues or fracture increases probability of inappropriate therapy: Inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.

Firm Action

Boston Scientific sent an Urgent Medical Device Information letter, dated March 23, 2009, to physicians following implanted devices. The letter described the issue, the rate of occurance and provided Patient Management Recommendations.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: USA, Guam, Puerto Rico, Aruba, Austria, Belgium, Brazil, Canada, Cayman Islands, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Netherlands, New Caledonia, Norway, Philippines, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom, and Venezuela.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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