Recall Z-1299-06 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T177). Implantable Cardioverter Defibrillators (ICD). Quantities Distributed by model are as follows: VITALITY model 1870 = 40, model 1871 = 1, model T125 = 613, model T127 = 49, model T135 = 536. VITALITY2 model T165 = 1,994, model T167 = 710, model T175 = 2,010, model T177 = 879.
| Date | Sep 28, 2006 (initiated Jun 24, 2006) |
| Status | Terminated |
| Reason | Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or incorrect sensing in the affected devices. |
| Root cause | Other |
| Action | A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices. |
| Quantity | 6,832 |
| Distribution | Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Ital |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.