Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model

FDA device recall Z-0269-2007 · posted 2006-12-16 · Terminated

Recall details

Recalling firm

Guidant Corporation

Reason for recall

Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.

Action taken

An Important Medical Device Information letter, dated 10/09/2006 was sent to physicians following patients with a potentially affected device. The letter describes the issue, provides for a projected rate of occurrence, and provides recommendations. An October 9, 2006 Product Advisory Letter, beginning October 30, 2006, was also sent to provide an update that further laboratory testing and analysis indicates that the nominal probability of malfunction is higher than their earlier prediction. Non-implanted devices have been retrieved.

Root cause

Other

Status

Terminated

Product code

LWP

Quantity affected

57 (46-USA, 11 Foreign- Renewal 4RF)

Distribution

Worldwide distribution ---- including states of CA, FL, GA, IA, IL, KY, MA, MO, NJ, NY, OH, PA, TX and countries of Italy, Netherlands, Sweden, United Kingdom.

Date initiated

2006-09-30

Date posted

2006-12-16

Date terminated

2007-04-01

Location

Saint Paul, MN