Recall Z-0955-05 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
VITALITY AVT, model A135 and model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
| 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 | 22,575 devices (19,446 implanted world wide) |
| 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.