CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac Resynchronization Therapy Defibrillator. Guidant Corporation Cardia

FDA device recall Z-1290-06 · posted 2006-07-27 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.

Action taken

An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion.

Root cause

Other

Status

Terminated

Product code

LWP

Quantity affected

3

Distribution

Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, Un

Date initiated

2006-05-15

Date posted

2006-07-27

Date terminated

2008-03-02

Location

Saint Paul, MN