Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0

FDA device recall Z-1293-06 · posted 2006-09-28 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or loss of pacing output without warning in the affected devices.

Action taken

A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.

Root cause

Other

Status

Terminated

Product code

LWP

Quantity affected

9,972

Distribution

Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, G

Date initiated

2006-06-24

Date posted

2006-09-28

Date terminated

2008-03-02

Location

Saint Paul, MN