Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricu

FDA device recall Z-0928-2013 · posted 2013-03-08 · Terminated

Recall details

Recalling firm

Sorin Group USA, Inc.

Reason for recall

Isoline defibrillation leads distributed may have internal insulation breach.

Action taken

Sorin C.R.M., srl sent an Urgent Medical Device Field Safety Notice dated January28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return any unused products by certified mail with signed acknowledgment form, patients should continue to be monitored by their physician field reps during notification visit, and customers should make sure all personnel involved in the management of patients implanted with affected product are aware of the information described in the Field Safety Notice. Customers with questions should contact their local Sorin representative at 1-610-304-9728. For questions regarding this recall call 303-467-6222.

Root cause

Device Design

Status

Terminated

Product code

MRM

Quantity affected

1376 Isoline leads

Distribution

Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Ira

Date initiated

2013-01-28

Date posted

2013-03-08

Date terminated

2015-12-09

Location

Arvada, CO