Recall Z-0956-05 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175; CONTACT RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511
| Date | Jun 30, 2005 (initiated Jun 17, 2005) |
| Status | Terminated |
| Reason | The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy. |
| Root cause | Other |
| Action | Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm. |
| Quantity | 2,204 devices (786 remain implanted worldwide) |
| Distribution | worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.