Recall Z-1679-2009 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110.
| Date | Jul 14, 2009 (initiated Mar 23, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 49,148 total |
| Distribution | 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 Cal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.