Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex XL Model Numbers: QuickFlex and QuickFlex

FDA device recall Z-1483-2012 · posted 2012-05-03 · Terminated

Recall details

Recalling firm

St Jude Medical CRMD

Reason for recall

Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.

Action taken

A recall communication was initiated on 4/3/12 with St. Jude Medical forwarding a Medical Device Advisory to all doctors who have received the St. Jude QuickSite and QuickFlex Left Ventricular CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter provides the doctors with the problems identified and actions to be taken. Doctors with any questions or concerns are instructed to contact their local St. Jude Medical representative or their Technical Services Department at (800) 722-3774. A Physician Device Advisory Notice for the QuickSite and QuickFlex Left Ventricular CRT Leads was issued on 4/3/12 to physicians who have received the recalled products. The notice provides the physicians with the problem identified and actions to be taken. Physicians are instructed to return any packaged product in hospital inventory to SJM Sales Representatives. For implanted product, due to the nature of the issue, externalized conductors may be observed with no electrical or performance anomalies. Therefore, prophylactic explant is not recommended. It is recommended that physicians continue to monitor their patients' implanted system at regularly scheduled intervals. A Medical Advisory and Inventory Management Information letter was sent on 4/3/12 to hospital administrators to notify them of the problems identified and the actions to be taken.

Root cause

Device Design

Status

Terminated

Product code

NIK

Quantity affected

101,000 units (59,000 units in US)

Distribution

Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Bahrain, Balkan, Baltic, Belarus, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czec

Date initiated

2012-04-03

Date posted

2012-05-03

Date terminated

2012-07-17

Location

Sylmar, CA