Recall Z-1107-05 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
VENTAK PRIZM AVT model no. 1900, 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 | Aug 16, 2005 (initiated Jul 25, 2005) |
| Status | Terminated |
| Reason | Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy. |
| Root cause | Other |
| Action | Urgent Medical Device Safety Information & Corrective Action letter dated 07/22/05 was either mailed or Federal Expressed to doctors. This letter informed doctors that Guidant was revising its original recommendations set forth in the June 17, 2005 letter because new information indicates that one of the original recommendations can increase the risk of a latching event. Contained in this letter were Clinical Implications and Revised Recommendations. |
| Quantity | 937 devices (approximately 550 currently implanted worldwide) |
| Distribution | Worldwide. In addition to the US other countries 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.