VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corp

FDA device recall Z-1107-05 · posted 2005-08-16 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LWP

Quantity affected

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,

Date initiated

2005-07-25

Date posted

2005-08-16

Date terminated

2008-04-07

Location

Saint Paul, MN